Devices and systems for obtaining conductance data and methods of manufacturing and using the same

ABSTRACT

Devices and systems for obtaining conductance data and methods of manufacturing and using the same. In at least one embodiment of a device of the present disclosure, the device is an elongated body with at least one groove defined therein, the at least one groove configured to receive one or more conductor wires therein. In another embodiment, the device is an elongated core body having a plurality of conductive elements positioned thereon and a coating to result in a device having an overall round-cross section.

PRIORITY

The present application is related to, claims the priority benefit of,and is a divisional patent application of, U.S. Nonprovisional patentapplication Ser. No. 13/646,129, filed Oct. 5, 2012 and issued as U.S.Pat. No. 9,734,938 on Aug. 15, 2017, which is related to, and claims thepriority benefit of, U.S. Provisional Patent Application Ser. No.61/543,899, filed Oct. 6, 2011, U.S. Provisional Patent Application Ser.No. 61/585,535, filed Jan. 11, 2012, and U.S. Provisional PatentApplication Ser. No. 61/644,685, filed May 9, 2012. The contents of eachof the foregoing are incorporated by reference in their entirety intothis disclosure.

BACKGROUND

In the medical arts, various medical devices are required to beeffective, durable, and small or compact so to meet the particular needsof physicians and/or other interventionalists. Conductive devices, whichcan be catheters, wires, and the like, having various electrodes thereonor therein need to be particularly compact so to fit within narrowbodily lumens like a patient's vasculature and various other luminalorgans, such as the heart.

Wires may be preferred over catheters due to their relatively smallersize and the ability to fit one or more wires within a catheter lumen,for example. However, given the size of a typical guidewire (0.014″ or0.035″ in diameter, for example), conductive wire placement along theguidewire having those dimensions typically increases the overallcross-sectional area of the guidewire, making the guidewire unsuitablefor certain applications.

Accordingly, a compact device useful to carry various conductive wiresand sensors, configured for various interventional uses within apatient's body, would be well received in the marketplace.

BRIEF SUMMARY

In at least one embodiment of a device of the present disclosure, thedevice comprises an elongated body with at least one groove definedtherein, wherein the at least one groove can be one groove, two grooves,three grooves, or four or more grooves, the at least one grooveconfigured to receive one or more conductor wires therein. In variousembodiments, the elongated body has an outer diameter betweenapproximately 0.010″ and approximately 0.050.″ In another embodiment,the elongated body has an outer diameter selected from the groupconsisting of approximately 0.014″ and 0.035″. In yet anotherembodiment, the at least one groove has a depth of approximately 0.003″.

In at least one embodiment of a device of the present disclosure, the atleast one groove has a width between approximately 0.003″ andapproximately 0.020″. In an additional embodiment, the at least onegroove has a width selected from the group consisting of approximately0.003″ and approximately 0.018″. In yet an additional embodiment, the atleast one groove is sized and shaped to receive at least four conductorwires therein. In another embodiment, the at least one groove is sizedand shaped to receive at least six conductor wires therein.

In at least one embodiment of a device of the present disclosure, the atleast one groove comprises one groove, and the at least one conductorwire comprises six wires. In another embodiment, the at least one groovecomprises six grooves, and the at least one conductor wire comprises sixwires. In yet another embodiment, the device further comprises the atleast one conductor wire positioned within the at least one groove. Inan additional embodiment, the at least one groove comprises one groove,and the at least one conductor wire comprises six wires. In yet anadditional embodiment, the at least one groove comprises six grooves,and the at least one conductor wire comprises six wires.

In at least one embodiment of a device of the present disclosure, the atleast one groove does not completely encapsulate the at least oneconductor wire when the at least one conductor wire is positionedtherein. In an additional embodiment, the at least one conductor wiresubstantially or completely spans a length of the elongated body. Inanother embodiment, a proximal end of the elongated body is configuredto effectively couple to a coupler unit. In yet another embodiment, thecoupler unit is selected from the group consisting of a current sourceand a data acquisition and processing system.

In at least one embodiment of a device of the present disclosure, thedevice further comprises at least one sensor positioned along theelongated body, the at least one sensor coupled to the at least one wirewhen the at least one wire is positioned within the at least oneelongated groove. In another embodiment, the at least one sensor isselected from the group consisting of an excitation electrode, adetection electrode, a pressure sensor, a thermistor, a pH sensor, and aterminal electrode connector array. In yet another embodiment, the atleast one groove comprises six grooves, the at least one conductor wirecomprises six wires, and the at least one sensor comprises five or sixsensors.

In at least one embodiment of a device of the present disclosure, thedevice further comprises a sheath positioned around at least a portionof the elongated body. In an additional embodiment, the elongated bodycomprises a non-conductive material, and the at least one conductor wirecomprises a conductive material. In yet an additional embodiment, theelongated body and the at least one conductor wire each comprises aconductive material. In another embodiment, the conductive material isselected from the group consisting of stainless steel, a nickel titaniumalloy (such as Nitinol), copper, a nickel alloy (such as Monel), and acombination thereof. In yet another embodiment, the elongated body hasone or more non-conductive coatings positioned around the elongated bodyto insulate the elongated body from the at least one conductor wire. Inan additional embodiment, the at least one conductor wire has one ormore non-conductive coatings positioned around the at least oneconductor wire.

In at least one embodiment of a device of the present disclosure, the atleast one groove is defined horizontally or helically around theelongated body. In another embodiment, the device further comprises acoupler unit coupled to a proximal end of the elongated body. In yetanother embodiment, a signal can be carried along the at least oneconductor wire to and/or from the coupler unit and the at least onesensor.

In at least one embodiment of a device of the present disclosure, theelongated body having the at least one groove defined therein issufficiently rigid so to be safely inserted into a patient. In anadditional embodiment, the device has a flexural rigidity of no lessthan 80% of a flexural rigidity of a second elongated body without atleast one groove defined therein, wherein the elongated body and thesecond elongated body comprise the same material and have the same outerdimensions. In yet an additional embodiment, the at least one groovecomprises one groove, and the flexural rigidity of the device is no lessthan approximately 16% of the flexural rigidity of the second elongatedbody. In another embodiment, the at least one groove comprises sixgrooves, and the flexural rigidity of the device is no less thanapproximately 20% of the flexural rigidity of the second elongated body.

In at least one embodiment of a device of the present disclosure, thedevice has a flexural rigidity of no less than 80% of a flexuralrigidity of a second elongated body without at least one groove definedtherein, wherein the elongated body and the second elongated bodycomprise the same material. In another embodiment, the at least onegroove comprises one groove, the elongated body has an outer diameter ofapproximately 0.013″, the second body has an outer diameter ofapproximately 0.0134″, and the flexural rigidity of the device is noless than approximately 96% of the flexural rigidity of the secondelongated body. In yet another embodiment, the at least one groovecomprises six grooves, the elongated body has an outer diameter ofapproximately 0.013″, the second body has an outer diameter ofapproximately 0.0134″, and the flexural rigidity of the device is noless than approximately 92% of the flexural rigidity of the secondelongated body.

In at least one embodiment of a device of the present disclosure, the atleast one groove has a pitch between approximately 0.030″ andapproximately 1.50″. In an additional embodiment, the at least onegroove has a pitch selected from the group consisting of approximately0.040″ and approximately 0.120″. In yet an additional embodiment, thedevice further comprises a coating positioned along the elongated bodywhere the at least one wire is positioned within the at least onegroove. In another embodiment, the device further comprises a bondingagent positioned along the elongated body where the at least one wire ispositioned within the at least one groove.

In at least one embodiment of a device of the present disclosure, thedevice further comprises the at least one conductor wire positionedwithin the at least one groove, and at least one sensor positioned alongthe elongated body, the at least one sensor coupled to the at least onewire. In another embodiment, the at least one conductor wire comprisesfour conductor wires, the at least one sensor comprises four sensors,and the four conductor wires are separately coupled to the four sensors.In yet another embodiment, the four sensors comprise two outerexcitation electrodes and two inner detection electrodes, wherein theexcitation electrodes are operable to generate an electric field withina luminal organ that can be detected by the detection electrodes.

In at least one embodiment of a device of the present disclosure, the atleast one groove comprises six grooves, the at least one conductor wirecomprises six conductor wires, and the at least one sensor comprisesfour or five sensors. In another embodiment, the at least one conductorwire comprises six conductor wires, the at least one sensor comprisesfour sensors and one thermistor, and four of the six conductor wires areseparately coupled to the four sensors, and the other two of the sixconductor wires are coupled to the thermistor. In yet anotherembodiment, the at least one conductor wire comprises six conductorwires, the at least one sensor comprises four sensors or six sensors,and the six conductor wires are either separately coupled to the sixsensors, or four of the conductor wires are coupled to four sensors andthe other two conductor wires are coupled to the fifth sensor. In anadditional embodiment, the six sensors comprise two outer excitationelectrodes, two inner detection electrodes, and two thermistor wireends, wherein the excitation electrodes are operable to generate anelectric field within a luminal organ that can be detected by thedetection electrodes, and wherein the thermistor wire ends are operableto detect a temperature of a fluid within the luminal organ.

In at least one embodiment of a device of the present disclosure, theelongated body defines a compliant portion positioned distal to animpedance portion, the impedance portion comprising one or moreimpedance electrodes and the compliant portion being relatively moreflexible than a portion of the elongated body having the at least onegroove defined therein. In another embodiment, the compliant portion isconfigured to assist a user with the delivery, positioning, and/oranchoring of the device within a luminal organ. In yet anotherembodiment, the device further comprises an atraumatic tip present at adistal end of the compliant portion, the atraumatic tip configured toavoid and/or limit the risk of puncture of a luminal organ by thedevice. In an additional embodiment, the elongated body further definesa connection portion at or near a proximal end of the device, theconnection portion configured so that the at least one conductor wiremay be electrically coupled to a coupler unit. In yet an additionalembodiment, the connection portion comprises at least one connector, theat least one connector coupled to the at least one conductor wire. Inanother embodiment, the at least one conductor wire comprises sixconductor wires, the at least one connector comprises six connectors,and the six conductor wires are separately coupled to the sixconnectors.

In at least one embodiment of a device of the present disclosure, theelongated body has a first portion having a first groove configurationand a second portion having second groove configuration, the firstgroove configuration and the second groove configuration each selectedfrom the group consisting of a clockwise spiral configuration, acounter-clockwise spiral configuration, and a straight configuration. Inanother embodiment, the first groove configuration and the second grooveconfiguration are configured to cancel negative effects of device whipand improve torque transfer. In yet another embodiment, the elongatedbody has a first portion having a first groove configuration, a secondportion having second groove configuration, and a third portion having athird groove configuration, the first groove configuration, the secondgroove configuration, and the third groove configuration each selectedfrom the group consisting of a clockwise spiral configuration, acounter-clockwise spiral configuration, and a straight configuration. Inan additional embodiment, the at least one groove is also configured toreceive a conductive polymer therein, the conductive polymer capable oftransmitting a signal therethrough.

In at least one embodiment of a device of the present disclosure, the atleast one groove comprises at least a first groove and a second groove,the first groove defined around the elongated body in a clockwiseconfiguration, and the second groove defined around the elongated bodyin a counter-clockwise configuration. In an additional embodiment, thefirst groove and the second groove cancel negative effects of devicewhip and improve torque transfer. In yet an additional embodiment, thedevice further comprises the at least one conductor wire positionedwithin the first groove. In another embodiment, the device furthercomprises a coating positioned within the second groove. In yet anotherembodiment, the at least one conductor wire positioned within the firstgroove and the coating positioned within the second groove cancelnegative effects of device whip and improve torque transfer.

In at least one embodiment of a device of the present disclosure, theelongated body has a first portion having a first groove configurationand a second portion having second groove configuration different fromthe first groove configuration. In another embodiment, the first portionand the second portion are in communication with one another at acoupler portion. In yet another embodiment, a circumferential notch isdefined at the coupler portion. In an additional embodiment, the devicefurther comprises a coupler positioned around the device at thecircumferential notch, the coupler configured to hold the at least oneconductor wire when positioned within the at least one groove.

In at least one embodiment of a device of the present disclosure, adistal end of the elongated body is tapered, and when at least oneconductor wire is positioned within the at least one groove, a distalportion of the at least one conductor wire is released at or near thetapered distal end of the elongated body. In an additional embodiment,the device further comprises a flexible coating positioned around atleast part of the elongated body, so that when the elongated body iscurved or bent, the flexible coating remains sufficiently around atleast part of the elongated body. In another embodiment, the one or moreconductor wires form an assembly of wires whereby each of the one ormore conductor wires are insulated from one another by way of a coating.In yet another embodiment, the device further comprises the assembly ofwires positioned within the at least one groove.

In at least one embodiment of a device of the present disclosure, theelongated body comprises a nonconductive material comprising carbonfiber and a flexible polymer. In another embodiment, the device furthercomprises an elongated core material positioned within the elongatedbody. In yet another embodiment, the elongated core material is selectedfrom the group consisting of stainless steel, copper and a nickeltitanium alloy.

In at least one embodiment of a device of the present disclosure, theelongated body comprises a nonconductive material, and the at least onegroove is defined therein by pushing or pulling the elongated bodythrough a die having an outer portion and one or more die tabs, the oneor more die tabs define the at least one groove. In an additionalembodiment, the device further comprises an elongated core materialpositioned within the elongated body, the elongated core materialselected from the group consisting of stainless steel, copper, and anickel titanium alloy. In yet an additional embodiment, the at least onegroove is defined therein in a spiral configuration by turning the dierelative to the elongated body when the elongated body is pushed orpulled therethrough. In another embodiment, the at least one groove isdefined therein in a spiral configuration by turning the elongated bodyrelative to the die when the elongated body is pushed or pulledtherethrough.

In at least one embodiment of a device of the present disclosure, theelongated body comprises a wavy configuration. In an additionalembodiment, the coupler unit comprises a tiered receptacle configured tofit the proximal end of the elongated body, the tiered receptaclecomprising an inner portion and an outer portion configured to receivethe elongated body having a first outer diameter or a second differentouter diameter. In another embodiment, a proximal end of the elongatedbody is configured to fit within an outer portion of an adapter, theadapter configured to fit within a coupler unit.

In at least one embodiment of a method to manufacture a device of thepresent disclosure, the method comprises the steps of positioning aplurality of conductor wires within an elongated shell, whereby theplurality of conductor wires are separate from one another, and fillingthe elongated shell with a first material, wherein when the firstmaterial is cured and/or cooled, the first material and the plurality ofconductor wires form an elongated device. In another embodiment, thefirst material comprises a nonconductive material comprising carbonfiber and a flexible polymer. In yet another embodiment, the methodfurther comprises the step of positioning a core metallic body withinthe elongated shell at or near a relative center of the elongated shellprior to filling the elongated shell with the first material.

In at least one embodiment of an impedance substrate of the presentdisclosure, the impedance substrate comprises a flexible materialsubstrate having an impedance portion with at least one impedanceelectrode and at least one first conductor wire positioned thereonand/or therein, the at least one first conductor wire operativelyconnected to the impedance portion and terminating at or near a proximalend of the impedance substrate, the impedance substrate configured tofit around at least part of an elongated body sized and shaped to fitwithin a mammalian body lumen. In another embodiment, the impedancesubstrate further comprises a temperature portion and at least onesecond conductor wire positioned thereon and/or therein, the at leastone second conductor wire operatively connected to the temperatureportion and terminating at or near a proximal end of the impedancesubstrate. In yet another embodiment, when the impedance substrate iswrapped around a portion of the elongated body having at least one firstelongated body conductor wire positioned thereon and/or therein, andwherein when the at least one first elongated body conductor wirecontacts the at least one first conductor wire, a signal may betransmitted from the impedance portion, through the at least one firstconductor wire, and through the at least one first elongated bodyconductor wire. In an additional embodiment, when the impedancesubstrate is wrapped around a portion of the elongated body having atleast one first elongated body conductor wire and at least one secondelongated body conductor wire positioned thereon and/or therein, andwherein when the at least one first elongated body conductor wirecontacts the at least one first conductor wire and the at least onesecond elongated body conductor wire contacts the at least one secondconductor wire, a first signal may be transmitted from the impedanceportion, through the at least one first conductor wire, and through theat least one first elongated body conductor wire, and a second signalmay be transmitted from the temperature portion, through the at leastone second conductor wire, and through the at least one second elongatedbody conductor wire.

In at least one embodiment of an impedance substrate of the presentdisclosure, the flexible material substrate is relatively thicker at thetemperature portion than at the impedance portion. In an additionalembodiment, when the impedance substrate is wrapped around a portion ofthe elongated body having a tapered portion, and wherein the temperatureportion of the impedance substrate is positioned at the tapered portionof the elongated body, the impedance substrate maintains a consistentouter dimension. In yet an additional embodiment, the flexible materialsubstrate is configured so that it can be wound around at least part ofthe elongated body.

In at least one embodiment of an connector substrate of the presentdisclosure, the connector substrate comprises a flexible materialsubstrate having a connection portion with at least one connector and atleast one first conductor wire positioned thereon and/or therein, the atleast one first conductor wire operatively connected to the connectionportion and terminating at or near a distal end of the connectorsubstrate, the connector substrate configured to fit around at leastpart of an elongated body sized and shaped to fit within a mammalianbody lumen. In another embodiment, when the connector substrate iswrapped around a portion of the elongated body having at least one firstelongated body conductor wire positioned thereon and/or therein, andwhen the at least one first elongated body conductor wire contacts theat least one first conductor wire, a signal may be transmitted throughthe at least one first elongated body conductor wire, through the atleast one first conductor wire, and to the connection portion.

In at least one embodiment of a device of the present disclosure, thedevice comprises an elongated body having at least one elongated bodyconductor wire positioned thereon and/or therein, an impedance substrateof the present disclosure positioned around at least part of theelongated body at a first end, and a connector substrate of the presentdisclosure positioned around at least part of the elongated body at asecond end, wherein a signal may be transmitted from the impedancesubstrate, through the at least one elongated body conductor wire, tothe connector substrate. In another embodiment, the impedance substrateand/or the connector substrate are coupled to the elongated body usingan adhesive. In yet another embodiment, the impedance substrate and/orthe connector substrate are shrink-wrapped or heat-shrinked around theelongated body.

In at least one embodiment of a device of the present disclosure, thedevice comprises an elongated body with at least one groove definedtherein, the at least one groove configured to receive a conductivepolymer therein, the conductive polymer capable of transmitting a signaltherethrough.

In at least one embodiment of a device of the present disclosure, thedevice comprises an elongated body with a plurality of conductor wiresembedded therein, each of the plurality of conductor wires separatedfrom one another by at least part of the elongated body, whereby theplurality of conductor wires are positioned around a perimeter of theelongated body. In another embodiment, each of the plurality ofconductor wires are surrounded by a coating. In yet another embodiment,the core body comprises a conductive material, and wherein the coatingcomprises a non-conductive material. In an additional embodiment, theplurality of conductor wires comprises six conductor wires.

In at least one embodiment of a device of the present disclosure, theplurality of conductive wires are not exposed along a surface of theelongated body. In an additional embodiment, the plurality of conductivewires are nominally exposed along a surface of the elongated body. Inyet an additional embodiment, approximately 10% or less of acircumference of the plurality of conductor wires are exposed along asurface of the elongated body.

In at least one embodiment of an elongated wrap of the presentdisclosure, the elongated wrap comprises a flexible wrap body having aplurality of conductor wires or traces positioned thereon and/or thereinaround a relative perimeter of the flexible wrap body, the flexible wrapbody configured to fit around at least part of an elongated body sizedand shaped to fit within a mammalian body lumen. In an additionalembodiment, the flexible wrap body is capable of adhering to theelongated body using an adhesive. In yet an additional embodiment, theflexible wrap body is capable of adhering to the elongated body by wayof heat-shrinking or shrink-wrapping. In another embodiment, theflexible wrap body is sized and shaped to fit around an elongated bodyhaving a diameter of approximately 0.0131″. In another embodiment, theflexible wrap body comprises a polyimide.

In at least one embodiment of an elongated wrap of the presentdisclosure, the plurality of conductor wires are within an assembly ofconductor wires. In another embodiment, the plurality of conductor wiresor traces are positioned along the flexible wrap body in a configurationselected from the group of a straight configuration and a helicalconfiguration. In yet another embodiment, the elongated wrap furthercomprises at least one portion selected from the group consisting of animpedance portion, a temperature portion, and connection portion. In anadditional embodiment, the plurality of conductor wires or tracescomprises thirty-six total conductor wires or traces.

In at least one embodiment of an elongated wrap of the presentdisclosure, the plurality of conductor wires have a cross-sectionselected from the group consisting of round, square, and rectangular. Inan additional embodiment, the plurality of conductor wires or traces areseparated by one or more shrink zones configured to shrink around anelongated body.

In at least one embodiment of an elongated wrap of the presentdisclosure, the elongated wrap comprises a flexible wrap body having aplurality of wide conductors embedded therein or positioned thereonand/or therein around a relative perimeter of the flexible wrap body,the flexible wrap body configured to fit around at least part of anelongated body sized and shaped to fit within a mammalian body lumen. Inanother embodiment, the plurality of conductor wires or traces areseparated by one or more shrink zones configured to shrink around anelongated body. In yet another embodiment, the plurality of wideconductors have a cross-section selected from the group consisting of arectangular cross-section or a quasi-rectangular cross-section. In anadditional embodiment, the elongated wrap further comprises at least oneportion selected from the group consisting of an impedance portion, atemperature portion, and connection portion.

In at least one embodiment of a device of the present disclosure, theelongated body comprises inherent properties of flexural rigidity,pushability, and torque transfer, wherein said properties are sufficientto permit a user to advance, retract, and steer the elongated body asdesired within a patient's luminal organ.

In at least one embodiment of a system of the present disclosure, thesystem comprises an exemplary device of the present disclosure and acoupler unit, wherein a proximal end of the exemplary device isconfigured to effectively couple to the coupler unit.

In at least one embodiment of a method of manufacturing a device of thepresent disclosure, the method comprises the steps of introducing atleast one groove into an elongated body of a device, and positioning atleast one conductor wire within at least part of the at least onegroove. In another embodiment, the method further comprises the step ofapplying a coating of non-conductive material to at least part of theelongated body. In yet another embodiment, the method further comprisesthe step of applying an adhesive agent to the at least one groove and/orthe at least one conductor wire. In an additional embodiment, the methodfurther comprises the step of applying a coating to the at least oneconductor wire within the at least one groove.

In at least one embodiment of a method of manufacturing a device of thepresent disclosure, the method further comprises the step of applyingone or more electrodes and/or one or more thermistor electrodes to thedevice. In an additional embodiment, the method further comprises thestep of connecting the one or more electrodes and/or the one or morethermistor wire ends to one or more connectors by way of the at leastone conductive wire. In yet an additional embodiment, the at least oneconductor wire comprises at least four conductor wires.

In at least one embodiment of a method of using a device of the presentdisclosure, the method comprises the steps of inserting an exemplarydevice of the present disclosure into a luminal organ of a patient, andadvancing the exemplary device to a desired location within the patient.In another embodiment, the method further comprises the step ofactivating the exemplary device by applying a current therethrough. Inyet another embodiment, the method further comprises the step ofinjecting a fluid into the luminal organ so that the fluid passes one ormore electrodes of the exemplary device to facilitate one or moreimpedance readings. In an additional embodiment, the one or moreimpedance readings include those useful to ultimately determine one ormore of a fractional flow reserve, a coronary flow reserve, across-sectional area, and a temperature reading.

In at least one embodiment of a method of using a device of the presentdisclosure, a disease or a disorder of the patient may be diagnosed inconnection with one or more determinations. In another embodiment, themethod further comprises the step of withdrawing the exemplary devicefrom the patient.

In at least one embodiment of a device of the present disclosure, thedevice comprises an elongated core body having a length, a perimeter,and a cross-sectional configuration, a plurality of conductive elementspositioned around the perimeter of the core body and extending amajority of the length of the core body, the plurality of conductiveelements surrounded by a first substantially or completelynon-conductive coating, wherein the device, having the first (or atleast one) substantially or completely non-conductive coating, has anoverall round cross-section and an overall diameter betweenapproximately 0.013″ and approximately 0.050″. In another embodiment,the elongated core body has a plurality of grooves defined therein, eachof the plurality of grooves configured to receive at least one of theplurality of conductive elements therein. In yet another embodiment, theplurality of conductive elements comprises a plurality of conductivewires. In an additional embodiment, the elongated core body has aplurality of grooves defined therein, each of the plurality of groovesconfigured to receive at least one of the plurality of conductive wirestherein. In yet an additional embodiment, each of the plurality ofconductive wires is surrounded by the first substantially or completelynon-conductive coating.

In at least one embodiment of a device of the present disclosure, thedevice is further surrounded by a second substantially or completelynon-conductive coating, the second substantially or completelynon-conductive coating defining the overall round cross-section. In anadditional embodiment, the elongated core body is at least partiallysurrounded by the first substantially or completely non-conductivecoating, and wherein the plurality of conductive wires are notindividually coated prior to placement within the plurality of groovesIn yet an additional embodiment, the device is further surrounded by asecond substantially or completely non-conductive coating, the secondsubstantially or completely non-conductive coating defining the overallround cross-section.

In at least one embodiment of a device of the present disclosure, thecross-sectional configuration comprises a round cross-sectionalconfiguration. In another embodiment, the cross-sectional configurationcomprises a hexagonal cross-sectional configuration defining six planarsides. In yet another embodiment, the hexagonal cross-sectionalconfiguration further defines one or more reduced corners. In anadditional embodiment, the elongated core body is at least partiallysurrounded by the first substantially or completely non-conductivecoating, and wherein the plurality of conductive elements are positionedon the first substantially or completely non-conductive coating.

In at least one embodiment of a device of the present disclosure, theplurality of conductive elements comprise a plurality of conductor wireshaving a rectangular cross-section. In an additional embodiment, theplurality of conductive elements are positioned on the firstsubstantially or completely non-conductive coating using an adhesive. Inyet an additional embodiment, the device is further surrounded by asecond substantially or completely non-conductive coating, the secondsubstantially or completely non-conductive coating defining the overallround cross-section.

In at least one embodiment of a device of the present disclosure, thedevice is further surrounded by a second substantially or completelynon-conductive coating. In another embodiment, the device is furthersurrounded by a third substantially or completely non-conductivecoating, the third substantially or completely non-conductive coatingdefining the overall round cross-section. In yet another embodiment,each of the plurality of conductive elements is surrounded by the firstsubstantially or completely non-conductive coating. In an additionalembodiment, the device is further surrounded by a second substantiallyor completely non-conductive coating, so that the second substantiallyor completely non-conductive coating surrounds at least part of theplurality of conductive elements surrounded by the first substantiallyor completely non-conductive coating. In an additional embodiment, thedevice is further surrounded by a third substantially or completelynon-conductive coating, the third substantially or completelynon-conductive coating defining the overall round cross-section.

In at least one embodiment of a device of the present disclosure, theelongated core body is at least partially surrounded by the firstsubstantially or completely non-conductive coating, and wherein theplurality of conductive elements are positioned on the firstsubstantially or completely non-conductive coating. In an additionalembodiment, the plurality of conductive elements are selected from thegroup consisting of a plurality of conductive wires and a plurality ofconductive traces. In yet an additional embodiment, the plurality ofconductive elements comprises a plurality of conductive traces producedby initially placing one or more conductive traces upon the elongatedcore body at least partially surrounded by the first substantially orcompletely non-conductive coating and removing portions of the one ormore conductive traces to result in the plurality of conductive traces.In another embodiment, the plurality of conductive elements comprises aplurality of conductive traces produced by initially coating theelongated core body with a single conductive trace and removing portionsof the single conductive trace to result in the plurality of conductivetraces. In yet another embodiment, the plurality of conductive traceseach have a gap defined therebetween. In an additional embodiment, thedevice is further surrounded by a second substantially or completelynon-conductive coating, the second substantially or completelynon-conductive coating defining the overall round cross-section.

In at least one embodiment of a device of the present disclosure, theplurality of conductive elements comprise a plurality of conductivetraces. In another embodiment, the plurality of conductive traces areproduced by initially placing one or more conductive traces upon theelongated core body at least partially surrounded by the firstsubstantially or completely non-conductive coating and removing portionsof the one or more conductive traces to result in the plurality ofconductive traces. In an additional embodiment, the plurality ofconductive traces each have a gap defined therebetween. In yet anadditional embodiment, the device is further surrounded by a secondsubstantially or completely non-conductive coating, the secondsubstantially or completely non-conductive coating defining the overallround cross-section.

In at least one embodiment of a device of the present disclosure, theelongated core body comprises stainless steel, and wherein the pluralityof conductive elements comprise a material selected from the groupconsisting of gold and copper. In an additional embodiment, the devicefurther comprises a detector coupled to the device at or near a distalend of the device, the detector configured to obtain conductance datawhen the device is operated in a fluid environment. In yet an additionalembodiment, the detector is coupled to one or more of the plurality ofconductive elements, so that a signal may be transmitted along the oneor more of the plurality of conductive elements to and/or from thedetector. In another embodiment, the detector comprises two detectionelectrodes positioned in between two excitation electrodes, wherein theexcitation electrodes are operable to generate an electric field withina luminal organ that can be detected by the detection electrodes toobtain conductance data indicative of the luminal organ. In yet anotherembodiment, the device further comprises two thermistor wire endsoperable to detect a temperature of a fluid within the luminal organ.

In at least one embodiment of a device of the present disclosure, thedetector comprises part of an impedance substrate positioned upon thedevice. In an additional embodiment, the device further comprises aconnection portion coupled to the device at or near a proximal end ofthe device, the connection portion configured to transmit conductancedata from the plurality of conductive elements through the connectionportion to a coupler unit. In an additional embodiment, the connectionportion comprises part of a connector substrate positioned upon thedevice.

In at least one embodiment of a device of the present disclosure, thedevice comprises an elongated core body having a length, a perimeter,and a cross-sectional configuration selected from the group consistingof a round configuration and a hexagonal configuration, a plurality ofconductive elements positioned around the perimeter of the core body andextending a majority of the length of the core body, the plurality ofconductive elements surrounded by a first substantially or completelynon-conductive coating, and a detector coupled to the device at or neara distal end of the device and operably connected to one or more of theplurality of conductive elements, the detector configured to obtainconductance data when the device is operated in a fluid environment andto transmit the conductance data along one or more of the plurality ofconductive elements, wherein the device, having the first (or at leastone) substantially or completely non-conductive coating, has an overallround cross-section and an overall diameter between approximately 0.013″and approximately 0.050″. In another embodiment, the detector comprisestwo detection electrodes positioned in between two excitationelectrodes, wherein the excitation electrodes are operable to generatean electric field within a luminal organ that can be detected by thedetection electrodes to obtain conductance data indicative of theluminal organ. In yet another embodiment, the device further comprisestwo thermistor wire ends operable to detect a temperature of a fluidwithin the luminal organ. In an additional embodiment, the detectorcomprises part of an impedance substrate positioned upon the device. Inyet an additional embodiment, the plurality of conductive elements areselected from the group consisting of a plurality of conductive wiresand a plurality of conductive traces.

In at least one embodiment of a device of the present disclosure, thedevice further comprises a connection portion coupled to the device ator near a proximal end of the device, the connection portion configuredto transmit conductance data from the plurality of conductive elementsthrough the connection portion to a coupler unit.

In at least one embodiment of a method of preparing a device of thepresent disclosure, the method comprises the steps of positioning aplurality of conductive elements upon an elongated conductive core toform a partial device, and applying an outer substantially or completelynon-conductive coating to the partial device so that the device, havingthe outer substantially or completely non-conductive coating appliedthereon, has an overall round cross-section and an overall diameterbetween approximately 0.013″ and approximately 0.050″. In an additionalembodiment, the positioning step is performed by positioning theplurality of conductive elements upon the elongated conductive core thatis surrounded by an inner substantially or completely non-conductivecoating. In an additional embodiment, the method further comprises thestep of connecting a detector to the device at or near a distal end ofthe device, the detector configured to obtain conductance data when thedevice is operated in a fluid environment. In another embodiment, theconnecting step is performed by connecting the detector to one or moreof the plurality of conductive elements so that a signal may betransmitted along the one or more of the plurality of conductiveelements to and/or from the detector. In yet another embodiment, theconnecting step is performed by connecting the detector comprising twoinner detection electrodes and two outer excitation electrodes to two ormore of the plurality of conductive elements so that a signal may betransmitted along the two or more of the plurality of conductiveelements to and/or from the detector.

In at least one embodiment of a method of preparing a device of thepresent disclosure, the connecting step is further performed byconnecting two thermistor wire ends to two or more of the plurality ofconductive elements so that a signal may be transmitted from the twothermistor wire ends along the two or more of the plurality ofconductive elements. In another embodiment, the positioning step isperformed by positioning the plurality of conductive elements within aplurality of grooves defined within the elongated conductive core. Inyet another embodiment, the positioning step is performed by positioningthe plurality of conductive elements upon the elongated conductive corehaving a hexagonal cross-section so that each conductive element of theplurality of conductive elements is positioned on a separate side of theelongated conductive core. In an additional embodiment, the positioningstep is performed by positioning the plurality of conductive elementsupon the elongated conductive core that is surrounded by an innersubstantially or completely non-conductive coating. In yet an additionalembodiment, the positioning step further comprises applying a middlesubstantially or completely non-conductive coating to the partialdevice.

In at least one embodiment of a method of preparing a device of thepresent disclosure, the positioning step is performed by positioning theplurality of conductive elements comprising a plurality of conductivetraces upon the elongated conductive core that is surrounded by an innersubstantially or completely non-conductive coating. In an additionalembodiment, the method further comprises the step of etching at leastone of the plurality of conductive elements to increase an overallnumber of conductive elements. In yet an additional embodiment, thepositioning step is performed by positioning the plurality of conductivetraces upon the elongated conductive core having a cross-sectionselected from the group consisting of a round cross-section and ahexagonal cross-section. In another embodiment, the step of connectingthe detector to the device is performed by connecting the detectorcomprising part of an impedance substrate to the device.

In at least one embodiment of a method of preparing a device of thepresent disclosure, the method further comprises the step of connectinga connection portion to the device at or near a proximal end of thedevice, the connection portion configured to transmit conductance datafrom the plurality of conductive elements through the connection portionto a coupler unit. In another embodiment, the step of connecting theconnection portion to the device is performed by connecting theconnection portion comprising part of a connector substrate to thedevice.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosed embodiments and other features, advantages, anddisclosures contained herein, and the matter of attaining them, willbecome apparent and the present disclosure will be better understood byreference to the following description of various exemplary embodimentsof the present disclosure taken in conjunction with the accompanyingdrawings, wherein:

FIG. 1A shows a perspective view of a device according to an exemplaryembodiment of the present disclosure;

FIG. 1B shows a cross-sectional view of the device of FIG. 1A, accordingto an exemplary embodiment of the present disclosure;

FIG. 1C shows a perspective view of a device according to anotherexemplary embodiment of the present disclosure;

FIG. 1D shows a cross-sectional view of the device of FIG. 1C, accordingto an exemplary embodiment of the present disclosure;

FIG. 2A shows a line drawing perspective view of a device according toan exemplary embodiment of the present disclosure;

FIG. 2B shows a side view of a device coupled to a coupler unit,according to an exemplary embodiment of the present disclosure;

FIG. 3A shows a perspective view of a core wire prior to having anygrooves defined therein, according to an exemplary embodiment of thepresent disclosure;

FIG. 3B shows a perspective view of a device body having a plurality ofgrooves defined therein and a plurality of wires positioned therein,according to an exemplary embodiment of the present disclosure;

FIG. 3C shows a perspective view of a device body having a single groovedefined therein and a plurality of wires positioned therein, accordingto an exemplary embodiment of the present disclosure;

FIG. 3D shows a schematic representative of flexural rigidity testing,according to an exemplary embodiment of the present disclosure;

FIG. 3E shows a chart depicting the percentage degradation of flexuralrigidity versus the outer diameter of a device, according to variousexemplary device embodiments of the present disclosure;

FIGS. 4A and 4B show a series of devices of the present disclosurehaving various groove pitches, according to an exemplary embodiments ofthe present disclosure;

FIGS. 5A and 5B show devices having a single groove with and without aplurality of wires positioned therein, according to an exemplaryembodiment of the present disclosure;

FIGS. 6A and 6B show devices having a single groove and a plurality ofgrooves and a plurality of wires positioned therein and a coatingpositioned thereon, according to an exemplary embodiment of the presentdisclosure;

FIG. 6C shows a chart depicting the effect of pitch on the degradationof flexural rigidity, according to exemplary device embodiments of thepresent disclosure;

FIGS. 7A-7C show additional devices according to exemplary embodimentsof the present disclosure;

FIG. 8A shows a device having various components, electrodes, andconnectors positioned thereon, according to an exemplary embodiment ofthe present disclosure;

FIG. 8B shows a distal portion of device having various electrodespositioned thereon, according to an exemplary embodiment of the presentdisclosure;

FIG. 9A shows a cut-away side view of a portion of a device with agroove defined therein, according to an exemplary embodiment of thepresent disclosure;

FIG. 9B shows a proximal portion of device having various connectorspositioned thereon, according to an exemplary embodiment of the presentdisclosure;

FIG. 10 shows steps of a method of manufacturing a device, according toan exemplary embodiment of the present disclosure;

FIG. 11 shows steps of a method of using a device, according to anexemplary embodiment of the present disclosure;

FIGS. 12A-12D show side views of devices with two groove configurations,according to exemplary embodiments of the present disclosure;

FIGS. 13A-13D show side views of devices with two groove configurations,according to exemplary embodiments of the present disclosure;

FIG. 14A shows a side view of a device with grooves and a conductivepolymer positioned therein, according to an exemplary embodiment of thepresent disclosure;

FIGS. 14B, 14C, and 15A show side views of a device with clockwise andcounter-clockwise groove configurations, according to exemplaryembodiments of the present disclosure;

FIG. 15B shows a coupler configured to fit around a device, according toan exemplary embodiment of the present disclosure;

FIGS. 15C and 15D show side views of devices with two grooveconfigurations, according to exemplary embodiments of the presentdisclosure;

FIG. 16A shows an impedance substrate with an impedance portion and atemperature portion, according to an exemplary embodiment of the presentdisclosure;

FIG. 16B shows the impedance substrate of FIG. 16A positioned next to anelongated body, according to an exemplary embodiment of the presentdisclosure;

FIG. 16C shows the impedance substrate of FIG. 16A positioned upon partof an elongated body, according to an exemplary embodiment of thepresent disclosure;

FIG. 16D shows the impedance substrate of FIG. 16A wrapped around partof an elongated body, according to an exemplary embodiment of thepresent disclosure;

FIG. 16E shows a connector substrate with an impedance portion and atemperature portion, according to an exemplary embodiment of the presentdisclosure;

FIG. 16F shows the connector substrate of FIG. 16E positioned next to anelongated body, according to an exemplary embodiment of the presentdisclosure;

FIG. 16G shows the connector substrate of FIG. 16E positioned upon partof an elongated body, according to an exemplary embodiment of thepresent disclosure;

FIG. 16H shows the connector substrate of FIG. 16E wrapped around partof an elongated body, according to an exemplary embodiment of thepresent disclosure;

FIG. 16I shows an impedance substrate and a connector substrate wrappedaround part of an elongated body, according to an exemplary embodimentof the present disclosure;

FIG. 17A shows an impedance substrate having a relatively larger sizenear a temperature portion, according to an exemplary embodiment of thepresent disclosure;

FIG. 17B shows a core body having a tapered portion, according to anexemplary embodiment of the present disclosure;

FIG. 17C shows an impedance substrate configured for coiling around acore body, according to an exemplary embodiment of the presentdisclosure;

FIG. 17D shows a device having a curvature and a coating positionedthereon, according to an exemplary embodiment of the present disclosure;

FIG. 18A shows a cross-sectional view of a conductor wire assembly,according to an exemplary embodiment of the present disclosure;

FIG. 18B shows a portion of a conductor wire assembly placed within agroove of a core body, according to an exemplary embodiment of thepresent disclosure;

FIG. 19A shows the proximal ends of two devices positioned relative to acoupler unit, according to an exemplary embodiment of the presentdisclosure;

FIG. 19B shows the proximal ends of two devices and an adapterpositioned relative to a coupler unit, according to an exemplaryembodiment of the present disclosure;

FIG. 20A shows a cross-sectional view of a device having a first portionsurrounding a second portion, according to an exemplary embodiment ofthe present disclosure;

FIG. 20B shows a cross-sectional view of a device having a first portionsurrounding a second portion and grooves formed in the first portion,according to an exemplary embodiment of the present disclosure;

FIG. 20C shows a cross-sectional view of a die used to manufacture adevice, according to an exemplary embodiment of the present disclosure;

FIG. 20D shows a cross-sectional view of a device having a first portionsurrounding a second portion and conductor wires positioned in the firstportion, according to an exemplary embodiment of the present disclosure;

FIGS. 20E-20H show cross-sectional views of devices having conductorwires embedded therein, according to exemplary embodiments of thepresent disclosure;

FIG. 201 shows a close-up view of a portion of a cross-section of adevice with a conductor wire therein, according to an exemplaryembodiment of the present disclosure;

FIGS. 21 and 22 show wraps having conductive elements positionedtherein, according to exemplary embodiments of the present disclosure;

FIG. 23 shows a side view of a device having a wavy configuration,according to an exemplary embodiment of the present disclosure;

FIGS. 24A and 24B show cross-sectional views of devices having corebodies with flat sides and wide conductors placed thereon, according toexemplary embodiments of the present disclosure;

FIGS. 25A, 25B, and 25C show cross-sectional configurations of variouscore bodies, according to exemplary embodiments of the presentdisclosure;

FIGS. 26A-28A show cross-sectional configurations of various deviceshaving conductive elements therein, according to exemplary embodimentsof the present disclosure;

FIG. 28B shows exemplary profiles of device distal ends, according toexemplary embodiments of the present disclosure;

FIG. 29A shows a distal portion of a device, according to an exemplaryembodiment of the present disclosure;

FIG. 29B shows an impedance substrate, according to an exemplaryembodiment of the present disclosure; and

FIG. 29C shows a distal portion of a device with an impedance substratepositioned thereon, according to an exemplary embodiment of the presentdisclosure.

An overview of the features, functions and/or configurations of thecomponents depicted in the various figures will now be presented. Itshould be appreciated that not all of the features of the components ofthe figures are necessarily described. Some of these non-discussedfeatures, such as various couplers, etc., as well as discussed featuresare inherent from the figures themselves. Other non-discussed featuresmay be inherent in component geometry and/or configuration.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It will nevertheless be understood that no limitationof the scope of this disclosure is thereby intended.

In at least one embodiment of a device 100 of the present application,device 100 comprises an elongated body 102 having at least one groove104 defined therein. Groove 104, in various embodiments, is configuredto receive one or more conductor wires 110 therein.

FIGS. 1A and 1B show perspective and cross-sectional views,respectively, of an exemplary device 100 of the present disclosure,whereby body 102 is a solid body having a single groove 104 definedtherein. As shown in FIG. 1B, an exemplary body 102 has an outerdiameter of 0.014″, a groove 104 depth of approximately 0.003″, and arelative groove width of approximately 0.018″. In other embodiments,different sizes/measurements may be used, such as a 0.035″ outerdiameter body 102, smaller or larger outer diameter bodies 102, and/orsmaller or larger groove 104 depths and relative widths. In variousembodiments, body 102 has an outer diameter between approximately 0.010″and approximately 0.050.″

FIGS. 1C and 1D show perspective and cross-sectional views,respectively, of an exemplary device 100 of the present disclosure,whereby body 102 is a solid body having a plurality of grooves 104defined therein. As shown in FIG. 1D, six grooves 104 are definedtherein, and in other embodiments, more or fewer grooves 104 may bedefined therein. In at least one embodiment, and as shown in FIG. 1D, anexemplary body 102 has an outer diameter of 0.014″, and a groove 104depth and relative width of approximately 0.003″ each.

A line-drawing perspective view of an exemplary device 100 embodiment isshown in FIG. 2A. As shown in FIG. 2A, device 100 comprises a body 102having a plurality of grooves 104 defined therein, whereby a groove 104does not completely encapsulate a conductor wire 110 when conductor wire110 is positioned therein.

As shown in FIG. 2B, grooves 104 of device 100 are configured so thatconductor wires 110 present therein can substantially or completely spanthe length of device 100. In such an embodiment, a proximal end 200 ofconductor wire 110 can effectively connect to a coupler unit 210 suchas, for example, a console, a current source, a data acquisition andprocessing system, and/or the like, and so that another portion ofconductor wire 110, such as a distal end 202 and/or an internal portion204 of conductor wire 110, can couple to and/or form a sensor 220, suchas an excitation electrode, a detection electrode, a pressure sensor, athermistor, a pH sensor, a terminal electrode connector array and/or thelike. An exemplary sensor 220 of the present disclosure may be one ormore of an electrode 802, 804, 806, 808 and/or a thermistor (temperatureportion 810, having thermistor wire ends 812, 814, as referenced infurther detail herein). In addition, and in at least one embodiment, asheath 230 may be positioned around at least a portion of body 102, asshown in FIG. 2B, to cover at least part of device 100. As referencedherein, and as shown in FIG. 2B, an exemplary system 250 of the presentdisclosure comprises an exemplary device 100 of the present disclosureand at least one other component, such as, for example, a coupler unit210.

In various embodiments, body 102 comprises a non-conductive material,and conductor wires 110 comprise a conductive material. In otherembodiments, and as described in further detail herein, body 102 andconductor wires 110 are each conductive, and a non-conductive material,such as one or more non-conductive coatings 500 positioned around body102 and/or one or more conductor wires 110, may be used to effectivelyinsulate body 102 from conductor wires 110.

In various embodiments, grooves 104 can be defined in variousconfigurations along body 102, such a horizontally (or substantiallyhorizontally) as shown in FIG. 2A, helically (or substantiallyhelically) as shown in FIGS. 1A-1D, and/or another configuration wherebya conductor wire 110 present therein is capable of carrying a signal(data, electrical, and/or otherwise) along conductor wire 110, to and/orfrom a coupler unit 210 and/or a sensor 220, for example.

FIG. 3A shows an exemplary core wire used as a body 102 of the presentapplication prior to having any grooves therein. As shown in FIG. 3A,body 102 is an elongated core wire which may be comprised of stainlesssteel, a nickel titanium alloy (such as Nitinol), copper, a nickel alloy(such as Monel), a combination of the foregoing, and/or another materialsuitable as a conductor wire 110 that is sufficiently rigid, when one ormore grooves 104 are present therein, to be safely inserted into apatient. FIG. 3B shows an exemplary device 100 of the present disclosurehaving six grooves 104 defined within body 102 and showing six separateconductor wires 110, wherein one conductor wire 110 positioned withineach groove 104. FIG. 3C shows another exemplary device 100 of thepresent disclosure, whereby a single helical groove 104 is definedwithin body 102, whereby the single helical groove 104 is sized andshaped to receive all six conductor wires 110 therein. In various otherembodiments of devices 100 of the present disclosure, devices 100 mayhave a single groove 104 or two or more grooves 104, and said grooves104 may be horizontal along a horizontal axis of body 102, helicallyaround body 102, or in some other configuration around body 102.

The exemplary device 100 embodiments shown in FIGS. 3B and 3C weretested, in various experiments, to determine the flexural rigiditiesrelative to each other and relative to the core, ungrooved body shown inFIG. 3A. In each experiment, a body 102 having an outer diameter of0.013″ was tested, and conductor wires 110 of 0.002″ in diameter wereused. A calculated flexural rigidity (EI=FL³/(3δ), wherein EI is theflexural rigidity of dimension N·mm² (a combination of E, which is theeffective Young's Modulus of the composite material and I is the secondmoment of inertia), F is the downward pull force at the end of theexposed length of the body used in the test, L is the exposed length ofthe body used in the test, and δ is the spatial deflection at the freeend due to the overall downward pull force. A flexural rigidity of 116.7for the core body shown in FIG. 3A was obtained as compared to 98.95 (a15.2% decrease) for the device 100 shown in FIG. 3B and as compared to93.84 (a 19.6% decrease) for the device 100 shown in FIG. 3C. In variousembodiments, flexural rigidity increased to 108.79 (a 3.79% decreasecompared to the core shown in FIG. 3A) for a device 100 shown in FIG. 3Bhaving an increased body 102 diameter of 0.0134″, and a correspondingflexural rigidity of 107.85 (a 7.58% decrease compared to the core shownin FIG. 3A) for a device 100 shown in FIG. 3C having an increased body102 diameter of 0.0134″.

The above-referenced data was obtained whereby the exposed length (L) ofthe body was 3.07 mm, as shown in FIG. 3D. FIG. 3E shows a graph of thedata (percentage degradation of flexural rigidity versus the outerdiameter of the wire), whereby the largest percentage degradation existsat the most narrow diameter wire embodiments. As shown therein, andconsistent with the data above, an increase of 0.004″ has a significanteffect on flexural rigidity.

As the core body, comprising one or more materials described herein, hasthe highest flexural rigidity given that there are no grooves therein(so that a relative 100% of body mass is preserved), any grooves 104 cutor otherwise defined within body 102 would serve to decrease the overallflexural rigidity. At least one optimally designed device 100 of thepresent disclosure, depending on intended use, would have as high of aflexural rigidity as possible compared to a desired flexural rigidity ofa core body (used as an interventional guidewire, for example) and beprepared at as low of a cost as possible. In view of the same, anddepending on the mechanism used to introduce grooves 104 into body 102,a fewer number of grooves may result in a lesser overall manufacturingcost.

FIGS. 4A and 4B show portions of various exemplary embodiments ofdevices 100 of the present disclosure having a single groove 104 definedtherein. FIG. 4A shows a series of devices 100 having various pitches(the number of turns in a given length), with the smallest pitch (topdevice 100 device shown therein) of 0.040″ and the largest pitch (thebottom device 100 shown in FIG. 4A) of 1.050″. The larger the pitch, themore that the groove 104 formed a relatively flat portion of body 102.Additional exemplary device 100 embodiments may have a smaller or largerpitch than those shown in FIGS. 4A and 4B. FIG. 4B shows a closer viewof two of the devices 100 shown in FIG. 4A, namely devices 100 havingpitches of 0.040″ and 1.050″, respectively. In various embodiments,devices 100 have pitches between approximately 0.030″ and 1.50″.

FIGS. 5A and 5B show exemplary devices 100 of the present disclosure.FIG. 5A shows an exemplary device 100 having a 0.040″ pitch without (topfigure) and with (bottom figure) without conductor wires 110. FIG. 5Bshows an exemplary device 100 having a 1.050″ pitch without (top figure)and with (bottom figure) conductor wires 110. As shown in FIGS. 5A and5B, devices 100 have a single groove 104 defined therein, configured toreceive a plurality of conductor wires 110 therein. In these exemplaryembodiments, six conductor wires 110 are shown therein, wherebyconductor wires 110 span a length of device 100.

FIGS. 6A and 6B also show exemplary devices 100 of the presentdisclosure having a 1.050″ pitch, with FIG. 6A showing a device 100 withone groove 104 and FIG. 6B showing a device 100 with multiple grooves104. In the embodiment shown in FIG. 6A, multiple conductor wires 110are positioned within one groove 104, and in the embodiment shown inFIG. 6B, a single conductor wire 110 is positioned within each groove104. In these embodiments, at least part of device 100 is coated withpolyethylene terephthalate (PET), and as shown in FIG. 6B, for example,coating 600 is present along device 100 where the conductor wire(s) 110are positioned within groove 104. Other coatings 600 may be used, aswell as various agents 602 used to bond one or more conductor wires 110to device 100. Other potential coatings 600 include, but are not limitedto, thin-walled polymer jackets and various epoxies, and exemplaryagents 602 may include, but are not limited to, various epoxies and/orultraviolet light. As portions of device 100 have an intended use withina patient's body, coatings 500, 600 and/or agents 602, in variousembodiments, are used because they are biologically-compatible.

In various embodiments, coatings 500, 600 may be present around corebody 102 so to maintain an overall outer diameter although the coreitself may be tapered at or near the distal end of body 102. Forexample, and in at least one embodiment, distal end of body 102 may betapered down to 0.010″ from 0.014″, and a coating 500, 600 may bepositioned at or near the distal end in greater quantities than at thenon-tapered portion so to maintain a consistent overall outer diameter.In other embodiments of devices 100 of the present disclosure, thetapering may be from a first size to a second size, wherein the firstsize and second size differ from 0.010″ and 0.014″ as referenced aboveby way of example. Furthermore, and in various embodiments, the distalend of body 102 is tapered so to increase overall flex of that portionof body 102. Should an increase in overall flex of body 102 in itsentirety be desired, the overall outer diameter of body 102 could bedecreased. In at least one embodiment, the outer diameter of body 102 isdecreased by 0.006″ to increase flex.

FIG. 6C shows a chart depicting the effect of pitch on the degradationof flexural rigidity. As shown in FIG. 6C, device 100 embodiments havinga smaller relative pitch have a higher percentage of flexuraldegradation, noting that the single groove embodiments have a higherrelative percentage degradation than the six groove embodiments. Forexample, a single groove device 100 embodiment having a groove pitch of0.05″ has a 31.17% degradation as compared to an ungrooved wire, while asix groove device embodiment having the same pitch has only a 18.86%degradation.

FIGS. 7A and 7B show exemplary devices 100 of the present disclosurehaving various pitches. In these embodiments, at least part of device100 is coated with PET, and as shown in FIG. 7B, for example, coating600 is present along device 100 where the conductor wire(s) 110 arepositioned within groove(s) 104. FIG. 7C shows a comparison between anexemplary device 100 of the present disclosure having multiple grooves104 and a single conductor wire 110 within each groove 104, and anexemplary device 100 of the present disclosure having one groove 104 andmultiple conductor wires 110 therein.

FIG. 8A shows a side view of an exemplary device 100 of the presentdisclosure. As shown in FIG. 8A, device 100 comprises a body 102 havingat least one groove 104 defined within at least a part of body 102. InFIG. 8A, groove 104 is shown as being helically defined a relativelycentral portion of device 100. “Detail A,” as shown in FIG. 8A, is amagnified view of a portion of device 100 showing a plurality ofconductor wires 110 positioned within groove 104.

FIG. 8A also shows additional components of an exemplary embodiment ofdevice 100 of the present disclosure, including an impedance portion 800comprising one or more electrodes. As shown in FIG. 8A, four impedanceelectrodes (mechanically numbered as 1, 2, 3, and 4 below device 100 andlabeled with patent application reference numbers 802, 806, 808, 804above device 100), whereby electrodes 802, 804 comprise the relative twoouter electrodes, and wherein electrodes 806, 808 comprise the relativetwo inner electrodes. Electrodes 802, 804, in at least one embodiment,are referred to as the excitation electrodes, as electrodes 802, 804 areoperable to generate an electric field within a luminal organ that canbe detected by detection electrodes 806, 808. In at least one embodimentof a device 100 of the present disclosure, device 100 further comprisesa temperature portion 810 comprising two thermistor wire ends(mechanically numbered as 5 and 6 below device 100 and labeled withpatent application reference numbers 812, 814 above device 100), wherebythermistor wire ends 812, 814 are operable to detect a temperature of afluid, for example, within a luminal organ at the location of thermistorwire ends 812, 814.

FIG. 8A also shows a compliant portion 820 of device 100 positioneddistal to impedance portion 800. Compliant portion 820 is relativelymore flexible than the portion of device 100 having groove(s) 104 andwire(s) 110 positioned therein, as compliant portion 820 assists withthe potential delivery, positioning, and/or anchoring of device 100within a luminal organ. An atraumatic tip 822 is present at a distal endof compliant portion 820, in at least one embodiment of a device 100 ofthe present disclosure, so to avoid and/or limit the risk of puncture ofa luminal organ by device 100.

An exemplary device 100 of the present disclosure also comprises aconnection portion 830 located at or near a proximal end of device 100,whereby relative proximal ends of conductor wires 110 may beelectrically coupled to a coupler unit 210 such as, for example, currentsource, a data acquisition and processing system, and/or the like. Asshown in FIG. 8A, connection portion 830 includes connectors for each ofmechanically numbered items 1-6, which correspond to connectors 832,834, 836, 838, 840, 842. In at least one embodiment, electrode 802 iscoupled to a conductor wire 110 having a connector 832, positioned at ornear a proximal end of conductor wire 110. Similarly, electrode 806corresponds to connector 834, electrode 808 corresponds to connector836, electrode 804 corresponds to connector 838, thermistor wire end 812corresponds to connector 840, and thermistor wire end 814 corresponds toconnector 842, through one or more connector wires 110.

FIG. 8B shows a cut-away side view of an exemplary portion of a device100 (along A-A as shown in FIG. 8A) of the present disclosure. As showntherein, an exemplary device 100 has four electrodes, whereby each ofelectrodes 802, 806, 808, 804, from the distal end to the proximal end,are each effectively coupled to at least one connector wire 110. In atleast one embodiment, each of electrodes 802, 806, 808, 804 comprisering electrodes, noting that non-ring electrodes may also be used. Oneor more thermistor wire ends 812, 814 may also be coupled to connectorwires 110 as shown in FIG. 8B.

In various other embodiments of devices 100 of the present disclosure,devices 100 may have more or fewer electrode and/or wire components. Forexample, an exemplary device 100 of the present disclosure may have siximpedance electrodes and no thermistor, four impedance electrode and onethermistor, three thermistors and no impedance electrodes, and/or moreor less electrodes and/or thermistors. In embodiments with more thanfour impedance electrodes and one thermistor, more connector wires 110and more connectors would be present within and/or along device 100. Inan embodiment of a device 100 with fewer electrodes (or, for example,four electrodes and no thermistor), fewer connectors at the proximal endof device 100 would be required.

In addition, and in at least one embodiment of a device 100 of thepresent disclosure, body 102 (or a portion thereof) is conductive andcan be used in place of a conductive wire 110. For example, an impedanceelectrode, thermistor, pressure sensor, etc., can be coupled to body 102at or near the distal end of device 100, and a connector can be coupledto body 102 at the proximal end (or body 102 itself can operate as aconnector) in lieu of one or more conductor wires 110. In variousembodiments, one or more conductor wires 110 can be used along with body102 as a conductor.

FIGS. 9A and 9B show cut-away side views of exemplary portions ofdevices 100 of the present disclosure. As shown in FIG. 9A, a portion ofdevice 100 is shown (along B-B as shown in FIG. 8A) whereby conductorwires 110 are shown positioned within a groove 104 defined within body102 of device 100. FIG. 9B shows an exemplary connection portion 830(along C-C as shown in FIG. 8A), whereby conductor wires 110 are coupledto connectors 832, 834, 836, 838, 840, 842. As shown in the magnifiedview identified as “Detail B” within FIG. 9B, a conductor wire 110 isshown as extending to conductor 832 of device 100.

At least one embodiment of a method of manufacturing a device 100 of thepresent disclosure is shown in the block diagram of FIG. 10. As shown inFIG. 10, method 1000 comprises the step of introducing at least onegroove 104 into an elongated body 102 (an exemplary groove introductionstep 1002), and optionally applying a coating 500 (as shown in FIG. 2B)of non-conductive material to at least part of body 102 (an exemplarybody coating step 1004) so that when a conductor wire 110 is positionedwithin one or more grooves 104, conductor wires 110 are insulated frombody 102 in the event body 102 is conductive. Method 1000 also comprisesthe step of positioning at least one conductor wire 110 within at leastpart of groove 104 (an exemplary conductor wire positioning step 1008).An optional step of introducing an adhesive agent 602 to the groove 104and/or the conductor wire 110 may also be performed prior to performingthe exemplary conductor wire positioning step 1008 (an exemplaryadhesive application step 1006). Adhesive application step 1006 may alsobe performed after conductor wire positioning step 1008, whereby agent602 is applied to the conductor wire 110 after conductor wire 110 ispositioned within groove 104.

An exemplary method 1000 may further comprise the step of applying acoating 600 to conductor wire 110 within groove 104 or to the outside ofthe entire guidewire assembly (device 100) (an exemplary coating step1010) so to potentially protect conductor wire 110 within groove 104and/or improve the overall consistency of the outer profile of theportion of device 100 having groove(s) 104 and conductor wire(s) 110present therein. Such a step may be performed so that when device 100 isintroduced into a patient's body, for example, the introduction issmoother as there are less portions of device 100 to potentially getcaught and/or injure a luminal organ of a patient.

Method 1000, in at least one embodiment, would comprise the step ofapplying one or more electrodes 802, 804, 806, 808 and/or connecting oneor more thermistor wire ends 812, 814 to device 100 (an exemplaryelectrode application step 1012). Further, and in at least oneembodiment, method 1000 would comprise the step of effectivelyconnecting the one or more electrodes 802, 804, 806, 808 and/or one ormore thermistor wire ends 812, 814 to one or more connectors 832, 834,836, 838, 840, 842 by way of one or more conductor wires 110 (anexemplary connector coupling step 1014).

The present disclosure includes disclosure of a method of using anexemplary device 100 of the present disclosure. In at least one suchexemplary method 1100, method 1100 comprises the steps of inserting anexemplary device 100 of the present disclosure into a luminal organ of apatient (an exemplary device insertion step 1102) and advancing device100 to a desired location within the patient (an exemplary advancementstep 1104). Device 100 is then activated by way of applying a currenttherethrough (an exemplary activation step 1106) and one or more fluidinjections may be made so that the fluid passes the various electrodes802, 804, 806, 808 and/or thermistor electrodes 812, 814 to facilitateany number of impedance readings, such as those to ultimately determinefractional flow reserve (FFR), coronary flow reserve (CFR),cross-sectional area (CSA), and/or temperature readings (an exemplaryfluid injection step 1108). The use of fluid injections in connectionwith an impedance device has been previously described by Kassab et al.in U.S. Pat. No. 7,454,244, and one or more saline injections, forexample, as referenced in U.S. Pat. No. 7,454,244 could be performed toobtain impedance readings to be used as referenced herein and asreferenced in said patent. Method 1100 may also comprise obtaining oneor more impedance readings such as those to ultimately determine FFR,CFR, CSA, and/or temperature, based upon fluid native to the luminalorgan and not based upon and introduced bolus of fluid (an exemplarynative reading step 1110). Repeating exemplary fluid injection steps1108 and native reading steps 1110 would generate a series of impedancedata that could be used in connection with the aforementioneddeterminations and/or other determinations, such as potentiallydiagnosing a disease or disorder, based upon said readings anddeterminations. Method 1100 may then comprise the step of withdrawingdevice 100 from the patient (an exemplary device withdrawal step 1112).

Additional device 100 embodiments are also included within the presentdisclosure. For example, and as shown in FIGS. 12A and 12B, exemplarydevices 100 of the present disclosure may incorporate more than oneconfiguration of grooves 104 therein. As shown in FIGS. 12A and 12B, forexample, an exemplary device 100 of the present disclosure may have afirst portion 1200 of grooves 104 in a first configuration, and may havea second portion 1202 of grooves 104 in a second configuration.

FIG. 12A shows an exemplary device 100 of the present disclosure,wherein the first portion 1200 has one or more grooves 104 in aclockwise spiral configuration as viewed from the distal end of device100, an exemplary first configuration, and wherein the second portion1202 has one or more grooves 104 in a counter-clockwise spiralconfiguration, an exemplary second configuration. Such an alternatingconfiguration of grooves in opposite spiral directions, in at least oneembodiment, helps to cancel the negative effects of device 100 whip andimprove overall torque transfer.

Torque transfer, as referenced herein, relates to the ability of adevice to transmit a turning (torque) from one portion of a device toanother. For example, and if considering an elongated device 100 havinga length, torque transfer can relate to a physical turning at or near aproximal end of device 100 that is transmitted to a distal end of device100. For example, if the proximal end of an exemplary device 100 wasturned clockwise 90°, and if the distal end of device 100 also turned90°, there would be 100% torque transfer. However, if the proximal endof device 100 was turned clockwise 90° and the distal end only turned45°, the torque transfer would only be 50%.

Whip, as referenced herein, relates to a second portion of a device“catching up” to the turning engagement, for example, of a first portionof the device. For example, if turning a proximal end of a device 180°only initially results in the distal end turning 135° (a 75% torquetransfer), and turning the proximal end of the device an additional 90°(for a total of 270°) causes to distal end to turn an additional 180°(also for a total of 270°), that latter distal end rotation is referredto as a whip, as the rotation of the distal end effectively “catches up”with the rotation at the proximal end. Whip can also refer toovercompensation of the second portion due to rotation of the firstportion. For example, and in the example referenced above, if theadditional proximal end turning of 90° (for a total turning of 270°)results in the distal end turning an additional 180° (for a total of315°), the whip caused the distal end to overcompensate by an extra 45°.A “perfect” device 100, as referenced herein, would have perfect torquetransfer and zero whip.

FIG. 12B shows an exemplary embodiment of a device 100 of the presentdisclosure, wherein the first portion 1200 has one or more grooves 104in a counter-clockwise spiral configuration, and wherein the secondportion 1202 has one or more grooves 104 in a clockwise spiralconfiguration. Additional device 100 embodiments are shown in FIGS. 12Cand 12D, wherein one of the portions (1200 or 1202) has a spiralconfiguration, and wherein the other portion (1200 or 1202) has astraight configuration. Various device 100 embodiments of the presentdisclosure may have a first portion 1200 and second portion 1202 withdifferent configurations.

FIG. 13A shows an exemplary embodiment of a device 100 of the presentdisclosure, whereby device 100 has a first portion 1200, a secondportion 1202, and a third portion 1300, with at least one portion 1200,1202, 1300 having a different configuration than the remaining portions.In FIG. 13A, for example, device 100 has a first portion 1200 has one ormore grooves 104 in a clockwise spiral configuration, a second portion1202 with one or more grooves 104 in a counter-clockwise spiralconfiguration, and a third portion 1300, in between first portion 1200and second portion 1202, with one or more grooves 104 in a straightconfiguration. FIG. 13B shows an exemplary device 100 embodiment,whereby a first portion 1200 has one or more grooves 104 in acounter-clockwise spiral configuration, a second portion 1202 with oneor more grooves 104 in a clockwise spiral configuration, and a thirdportion 1300, in between first portion 1200 and second portion 1202,with one or more grooves 104 in a straight configuration. FIG. 13C showsa device 100 embodiment having straight, clockwise, and counterclockwisegroove 104 configurations, and FIG. 13D shows a device 100 embodimenthaving straight, counter-clockwise, and clockwise groove 104configurations. Other embodiments of devices 100 of the presentdisclosure may have additional portions with various configurations ofstraight, clockwise, and/or counter-clockwise groove 104 configurations,such as those with four or more portions.

FIG. 14A shows an additional device 100 embodiment of the presentdisclosure. As shown in FIG. 14A, device 100 comprises a body 102 havinga plurality of grooves 104 defined therein. In at least one groove 104(noting that the exemplary device 100 embodiment may have a singlegroove 104 instead of a plurality of grooves 104), a conductive polymer1400 is placed therein, and is used to transmit the signal to and/orfrom one or more sensors (such as the electrodes and/or thermistorsreferenced herein). In a number of embodiments referenced herein, thesignal(s) is/are is transmitted using one or more conductor wires 110placed within groove(s) 104, and in the embodiment shown in FIG. 14A, aconductive polymer 1400 is used instead of one or more conductor wires110. Conductive polymer 1400, as shown in FIG. 14A, is shown only withinpart of grooves 104 (so that conductive polymer 1400 can be visualizedin the figure as being different from grooves 104), but in variousactual embodiments, conductive polymer 1400 would need to extend fromthe sensors to the connection portion 830, for example, so that a signalcan be transmitted over that distance.

FIG. 14B shows an exemplary device 100 embodiment with a plurality ofgrooves 104 defined therein. As shown in FIG. 14, the body 102 of device100 has one or more grooves 104 in a clockwise spiral configuration andalso has one or more grooves 104 in an opposing counter-clockwise spiralconfiguration. One or more conductor wires 110 (as shown in FIG. 14A, oralternatively a conductive polymer 1400) can be positioned within one ofthe groove configurations, such as the clockwise configuration shown inFIG. 14A, and can be used to conduct signals as referenced herein. Suchan opposing groove 104 configuration, in at least one device 100embodiment, is defined within the body 102 of device 100 so to balanceoverall torque transfer and/or reduce instances of device 100 whip. FIG.14C shows another exemplary device 100 embodiment of the presentdisclosure, whereby conductor wires 110 (or alternatively, a conductivepolymer 1400) is positioned within one of the groove configurations(clockwise or counter-clockwise), and whereby a coating 500 (or coating600, as the case may be) is positioned in the other groove configurationto help further balance overall torque transfer and/or reduce instancesof device 100 whip. Coating 500, 600, in various embodiments, maycomprise various polymers, epoxies, adhesives, and/or other materialscapable of being placed within one or more grooves 104 and notinterfering with conductive wires 110 and/or conductive polymers 1400placed in other grooves and/or positioned about a surface of anexemplary device 100.

An additional device 100 embodiment of the present disclosure is shownin FIG. 15A. As shown therein, device 100 comprises a first portion 1200having one or more grooves 104 in a clockwise spiral configuration (asviewed from the distal end of device 100), and a second portion 1202 hasone or more grooves 104 in a counter-clockwise spiral configuration. Theone or more grooves 104 of first portion 1200 and second portion 1202are in communication with one another at a coupler portion 1500, so thatone or more conductor wires 100 positioned within grooves 104 can extendfrom first portion 1200 to second portion 1202. Coupler portion 1500, asshown in FIG. 15A, can include one or more notches 1502 defined therein,such as the circumferential notch 1502 as shown in the figure. Tofacilitate placement of conductor wires 110 within grooves 104, aportion of conductor wires 110 can be positioned, for example, withingroove(s) 104 of first portion 1200, and can be held in place at couplerportion 1500 using a coupler 1550, such as coupler 1550 shown in FIG.15B. Coupler 1550, as shown in FIG. 15B, may open and close at contact1552, so that coupler 1550 can be positioned around body 102 and closedto hold conductor wires 110 in place. Conductor wires 110 can then bepositioned within groove(s) 104 of second portion 1202, noting that thechange in rotation of grooves 104 (or change to/or from a straightto/from a spiral configuration) would not negatively affect conductorwire 110 positioning as coupler 1550 would sufficiently hold conductorwires 110 in place.

FIGS. 15C and 15D show additional device 100 embodiments, wherebygrooves 104 defined therein are effectively coupled (or in communicationwith) each other between the first portion 1200 and the second portion1202 of said devices. As shown in FIG. 15C, device 100 comprises a firstportion 1200 with a straight configuration of grooves 104, and a secondportion 1200 with a counter-clockwise configuration of grooves therein,whereby grooves 104 of each portion 1200, 1202 are in communication witheach other at coupler portion 1500. FIG. 15D shows a similar device 100embodiment, but the second portion 1202 has a clockwise groove 104configuration, and coupler portion 1500 includes a notch 1502 configuredto receive a coupler 1550 to hold conductor wires 110 in place.Additional embodiments are also possible, with various configurationsand numbers of portions, including those with multiple coupler portions1500 with optional multiple notches.

The present disclosure also includes disclosure of device 100 wherebyone or more conductive portions may be initially formed on a separatesubstrate and subsequently added to the body 102 of device 100. In atleast one embodiment, and as shown in FIG. 16A, an impedance substrate1600 may be initially separate from device 100, and subsequently addedto device 100 to form an operable impedance device 100. In at least oneembodiment, impedance substrate 1600 is configured to fit around atleast part of an elongated body (such as a body 102) sized and shaped tofit within a mammalian body lumen.

As shown in FIG. 16A, impedance substrate 1600 comprises a flexiblematerial 1602 capable of having conductors and electrodes positionedthereon and/or defined therein. In FIG. 16A, an exemplary impedancesubstrate 1600 has an impedance portion 800 (including electrodes 802,804, 806, 808, for example) positioned thereon, along with temperatureportion 810 with two thermistor wire ends 812, 814 thereon as well. Saiditems are coupled to at least one conductor wire 110 as shown on FIG.16A, with conductor wires 110 terminating at or near a proximal end 1602of impedance substrate 1600. Other embodiments of impedance substrates1600 of the present disclosure may, for example, comprise only animpedance portion 800 with conductor wires 110, or comprise only atemperature portion 810 with conductor wires 110. In variousembodiments, the impedance portion 800, temperature portion 810, and/orthe conductor wires 110 are deposited and/or printed on the impedancesubstrate 1600, as desired.

An exemplary impedance substrate 1600, such as shown in FIG. 16A, may beused in connection with an exemplary device 100 of the presentdisclosure as shown in FIGS. 16B and 16C. As shown in FIG. 16B, a body102 of an exemplary device 100 may have a series of grooves 104 definedtherein and one or more conductor wires 110 positioned therein. In otherembodiments, device 100 would not need to have any grooves 104 definedtherein, but would instead include one or more conductor wires 110adjacent to the body 102 of device 100, so that said conductor wires 110can contact the conductor wires 110 of impedance substrate 1600.

Conductor wires 110 may then terminate at or near the proximal end 1602of impedance substrate 1600 when impedance substrate 1600 is positionedthereon as shown in FIG. 16C. FIG. 16C shows an exemplary impedancesubstrate 1600 positioned relative to body 102 but not yet wrappedaround body 102, and FIG. 16D shows an exemplary impedance substrate1600 wrapped around body 102 to form an operable impedance device 100.To allow for such wrapping, impedance substrate 1600 must besufficiently flexible and sufficiently thin so not to detrimentallyincrease the overall diameter of device 100.

As referenced above, electrodes 802, 804, 806, 808 may be positioneddifferently in various embodiments. As generally referenced herein,electrodes 802 and 804 are the outer, excitation electrodes, andelectrodes 806 and 808 are the inner, detection electrodes. In variousembodiments, electrode 802 may be the most distal electrode, and inother embodiments, electrode 804 may be the most distal electrode, outof electrodes 802, 804, 806, 808.

Similarly, the present disclosure also includes disclosure of device 100whereby one or more connectors may be initially formed on a separatesubstrate and subsequently added to the body 102 of device 100. In atleast one embodiment, and as shown in FIG. 16E, a connector substrate1675 may be initially separate from device 100, and subsequently addedto device 100 to form an operable (or potentially operable) impedancedevice 100.

As shown in FIG. 16E, connector substrate 1675 comprises a flexiblematerial substrate 1685 capable of having connectors positioned thereonand/or defined therein. In FIG. 16E, an exemplary connector substrate1675 includes a connection portion 830 with connectors 832, 834, 836,838, 840, 842 positioned thereon. Said connectors are coupled to atleast one conductor wire 110 as shown on FIG. 16E, with conductor wires110 terminating at or near a distal end 1680 of connector substrate1675. Other embodiments of connector substrate 1675 of the presentdisclosure may, for example, comprise fewer or more connectors, wherebysaid connectors correspond to one or more sensors/electrodes at anotherportion of device 100. In various embodiments, the connectors aredeposited and/or printed on the connector substrate 1675, as desired.

An exemplary connector substrate 1675, such as shown in FIG. 16E, may beused in connection with an exemplary device 100 of the presentdisclosure as shown in FIGS. 16F and 16G. As shown in FIG. 16F, a body102 of an exemplary device 100 may have a series of grooves 104 definedtherein and one or more conductor wires 110 positioned therein. In otherembodiments, device 100 would not need to have any grooves 104 definedtherein, but would instead include one or more conductor wires 110adjacent to the body 102 of device 100, so that said conductor wires 110can contact the conductor wires 110 of connector substrate 1675.

Conductor wires 110 may then terminate at or near the distal end 1680 ofconnector substrate 1675 when connector substrate 1675 is positionedthereon as shown in FIG. 16G. FIG. 16G shows an exemplary connectorsubstrate 1675 positioned relative to body 102 but not yet wrappedaround body 102, and FIG. 16H shows an exemplary connector substrate1675 wrapped around body 102 to form an operable (or potentiallyoperable) impedance device 100. To allow for such wrapping, connectorsubstrate 1675 must be sufficiently flexible and sufficiently thin sonot to detrimentally increase the overall diameter of device 100. FIG.16I shows an exemplary device of the present disclosure having a body102, conductor wires 110 along body 102 (within grooves 104 and/orpositioned adjacent to body 102 not within grooves 104), an exemplaryimpedance substrate 1600 positioned at or near the distal end of body102 and wrapped around body 102, and a connector substrate 1675positioned at or near the proximal end of body 102 and wrapped aroundbody 102. Such a device 100 embodiment would entail the preparation oftwo flexible substrates with the various sensors/electrodes/connectorspositioned thereon.

So that impedance substrate 1600 and/or connector substrate 1675remain(s) coupled to body 102, an adhesive 1650 (or an adhesive 602) maybe positioned on the back of impedance substrate 1600, connectorsubstrate 1675, and/or about body 102, or a portion of impedancesubstrate 1600 and/or connector substrate may be heated and pressed ontobody 102 so that when the substrate cools, it remains coupled to body102. In addition, various elements of impedance substrate 1600 (such aselectrodes and other sensors) may be positioned onto impedance substrate1600 using an adhesive 1650, 602, such as a non-metallic epoxy or asilver epoxy, for example. Connectors may be coupled to connectorsubstrate 1675 in a similar fashion.

A side view of an exemplary impedance substrate 1600 of the presentdisclosure is shown in FIG. 17A. As shown therein, an exemplaryimpedance substrate 1600 has electrodes 802, 804, 806, 808 positionedthereon or defined therein, as well as a temperature portion 810positioned thereon or defined therein. In at least one embodiment,temperature portion 810 (such as a thermistor, for example), isphysically larger than electrodes 802, 804, 806, 808, and thereforerequires more impedance substrate 1600 at temperature portion 810. Sothat such an embodiment may still be wrapped around a portion of anexemplary device 100 of the present disclosure and maintain a desiredouter dimension, device 100 may be tapered at taper 1700 shown in FIG.17B, so that a proximal body portion 1702 has a relatively largercross-sectional area than a distal body portion 1704 distal to taper1700. In such an embodiment, a relatively larger portion of impedancesubstrate 1600 would be positioned about body 102 at or distal to taper1700, so that when impedance substrate 1600 is wrapped around body 102,desired device 100 outer dimensions are achieved. Taper 1700, in atleast one embodiment, is configured so that a portion of conductor wires110 positioned within body 102 (such as those within one or more grooves104 or otherwise embedded within body 102) can be “released” andsubsequently connected to one or more sensors/electrodes as desired. Inat least one embodiment the taper 1700 would cause the distal bodyportion 1704 to have a cross-sectional area down to 0.004″ to 0.005″from an initial cross-sectional area of, for example, 0.014″ or 0.035″.

An additional impedance substrate 1600 of the present disclosure isshown in FIG. 17C. Such an embodiment, as shown in FIG. 17C, isconfigured so that it can be wound about a portion of a body 102 of adevice 100 of the present disclosure, so that when properly would,conductor wires 110 properly contact one another across impedancesubstrate 1600, and wherein electrodes 802, 804, 806, 808 and/ortemperature portion 810 are properly aligned so that they operate asdesired. As shown in FIG. 17C, an exemplary impedance substrate 1600 mayhave an angled proximal end 1750 and/or an angled distal end 1752, sothat when impedance substrate 1600 is wound about a body 102, proximalend 1750 and distal end 1752 are perpendicular to the longitudinal axisof body 102. As referenced herein, various embodiments of impedancesubstrates 1600 and/or connector substrates 1675 may be used inconnection with various devices, including devices 100 of the presentdisclosure having grooves 104 therein, or other wires or catheters withor without grooves 104 defined therein.

Various device 100 embodiments of the present disclosure may have acoating 500 (or 600) positioned thereon, such as shown in FIG. 17D. Asshown in FIG. 17D, coating 500, 600 is sufficiently flexible so thatwhen body 102 of device 100 is curved/bent, coating 500, 600 remainssufficiently about body 102. In addition, coatings 500, 600 that aresufficiently flexible so not to negatively impact torque transfer and/orincrease the instance of whip are preferred, either by their materialcomposition, amount of coating, or both.

FIGS. 18A and 18B show an exemplary assembly 1800 of conductor wires 110useful with exemplary devices 100 of the present disclosure. FIG. 18Ashows a cross-sectional end view of an exemplary assembly, whereby theindividual conductor wires 110 are insulated/separated from one anotherusing an exemplary coating 500 (or 600) of the present disclosure. Suchan assembly 1800 allows all conductor wires 110 (such as two, four, six,or another number of conductor wires 110) to be positioned within agroove 104 of a body 102 of a device 100, such as the portion of adevice 100 shown in FIG. 18B. FIG. 18B shows a top view of such a device100, whereby assembly 1800, including the desired number of conductorwires 110, is positioned within a groove 104.

FIGS. 19A and 19B show exemplary embodiments of coupler units 210 of thepresent disclosure, such as, for example, a console, a current source, adata acquisition and processing system, and/or the like, configured toreceive various devices 100 of the present disclosure and/or connectorsconfigured to receive various devices 100 of the present disclosure.FIG. 19A shows the proximal ends of two exemplary devices 100 of thepresent disclosure (such as, for example, devices with a 0.014″ and a0.035″ outer diameter) with connection portions 830 shown thereon.Coupler unit 210, as shown in FIG. 19A, may have a tiered receptacle1900 having connector receivers 1902 therein, so that when a smallerouter diameter device 100 is inserted, the inner portion 1904 of tieredreceptacle 1900 would receive the device 100, and so that when a largerouter diameter device 100 is inserted, the outer portion 1906 of tieredreceptacle 1900 would receive the device 100. The connection portion 830of the inserted device would then contact a particular set of connectorreceivers 1902, which would signal to the coupler unit that a device 100of a particular size has been inserted. Coupler units 210 may, invarious embodiments, use a different set of settings, formulas, and/oroffsets depending on the size of the device 100 inserted, so that moreaccurate measurements may be obtained using a device 100 of a particularsize.

FIG. 19B shows an embodiment of a coupler unit 210 configured to receivean adapter 1950, whereby adapter 1950 is itself configured to receiveproximal ends of one or more devices 100 of different sizes. As shown inFIG. 19B, adapter 1950 has a tiered receiver portion 1952, whereby aninner portion 1954 of tiered receiver portion 1952 is configured toreceive a smaller outer diameter device 100, and further has an outerportion 1956 configured to receive a larger outer diameter device. A setof adapter connector receivers 1902 would then contact a connectionportion 830 of a device and coupler unit 210 would then know the size ofthe device 100 depending on which set of adapter connector receivers1902 contacts connection portion 830 of device 100. External connectors1960 of adapter 1950, in at least one embodiment and when in contactwith coupler unit 210, could be used to transmit one or more signalsfrom adapter 1950 to coupler unit 210 by way of connector receivers 1902of coupler unit 210. In at least one embodiment, and as shown in FIG.19B, adapter 1950 may have a memory portion 1970, whereby memory portion1970 could store various parameters, settings, formulas, offsets, andthe like, for use with coupler unit 210.

In addition to the foregoing, the present disclosure includes variousdevice 100 embodiments comprising different body 102 materials otherthan those previously described. For example, and in at least oneembodiment, an exemplary device 100 of the present disclosure couldcomprise a body 102 comprising a flexible polymer (such as an epoxy, apolyimide (such as Kapton), and/or another polycarbon) combined withcarbon fiber, so that the body 102 would have the strength anddurability of carbon fiber, but the added benefit of being more flexiblethan only a carbon fiber body 102 due to the epoxy and/or one or moreadditional polycarbons. So to minimize or eliminate the concerns withpotential device 100 breakage, a portion of device 100 could bereinforced with a metallic member, such as a metallic wire. An exemplarycross-section of such an embodiment is shown in FIG. 20A, whereby body102 comprises a first portion 2000 (comprising carbon fiber combinedwith epoxy and/or one or more other polycarbons) and a second portion2002 (comprising a thin metallic wire, for example, having across-sectional area larger than conductor wires 110). In at least oneembodiment, body 102 comprises a first portion 2000 comprising acombination of carbon fiber and epoxy, and a second portion 2002comprising a stainless steel wire, whereby first portion 2000 completelyor substantially surrounds second portion 2002. Such an embodiment wouldnot then require the need for an additional coating 500, 600 whenconductor wires 110 are placed adjacent to body 102, or within groovesdefined within the second portion 2002 as shown in FIG. 20B.

Such an embodiment of a body 102 (having a first portion 2000 and asecond portion 2002) may be easier to manufacture/extrude given itsmaterial properties. For example, and as shown in FIG. 20C, a die 2050having an outer portion 2052 and one or more die tabs 2054 positionedtherein could be used to define one or more grooves 104 within a body102 of an exemplary device 100 of the present disclosure. A body 102could be advanced (or pulled) through die 2050 to define one or moregrooves 104 within body 102, and a relative twisting of body 102 and/ordie 2050 during the process could cause the grooves 104 to have a spiralconfiguration (instead of a straight configuration of no twisting (oroffsetting twisting)) were to occur.

An exemplary device 100 of the present disclosure, using a non-metallicfirst portion 2000 as referenced above, may be manufactured as follows.An elongated shell 2075, as shown in cross-section in FIG. 20D, couldhouse one or more conductor wires 110, and material for a first portion2000 (such as a combination of carbon fiber and epoxy) could beintroduced into elongated shell 2075. Curing and/or cooling of saidmaterial, for example, would result in a device having one or more wires110 formed therein. An optional second portion 2002, such as a stainlesssteel wire, could also be positioned within elongated shell during themanufacturing process so that a device 100 with one or more wires 110formed in a first portion 2000 and a second portion 2002 resultstherefrom.

Regardless of method of formation, additional device 100 embodiments ofthe present disclosure are shown in FIGS. 20E-20F. As shown in FIG. 20E,for example, a plurality of conductor wires 110 may be positionedcompletely within core body 102 (as shown in cross-section), wherebycore body 102 is itself insulative (non-conductive) so that conductorwires 110 do not require any coating 500, 600. FIG. 20F shows anotherexemplary device 100 embodiment, whereby an optional coating 500 (or600) is positioned around conductor wires 110 and/or an optional coating500, 600 is positioned within openings 2090 used to house conductorwires 110, or by another configuration as described herein. As showntherein, and in at least one embodiment, conductor wires 110 areseparated from one another by at least part of core body 102, and arepositioned around a relative perimeter of body 102. In the embodimentsshown in FIG. 20E and FIG. 20F, conductor wires 110 are completelysubsurface, in that a particular cross-section of device 100 does nothave any conductor wires 110 exposed along a surface 2092 of device 100.

Additional embodiments of devices 100 of the present disclosure areshown in FIGS. 20G and 20H, whereby conductor wires 110, or a coating500 (or 600) positioned around conductor wires 110, are either onlyslightly exposed along a surface 2092 of body 102, or not exposed, butjust subsurface, so that the amount of body 102 between the surface 2092of body 102 and a conductor wire 110 (or a coating 500, 600 around aconductor wire 110) is nominal so to provide potential relatively easyaccess to conductor wire 110 by way of puncture of the surface 2092 ofbody 102. FIG. 201 shows a close-up view of a portion of a device 100,whereby a conductor wire 110 is only slightly exposed along a surface2092 of body 102. In at least one embodiment, approximately 10% or lessof a circumference of the conductor wires 110 are exposed along asurface 2092 of the elongated body.

Various devices 100 of the present application have various inherentproperties, such as, for example, flexural rigidity, pushability, andsteerability (torque transfer). Use of such a device 100 within apatient's body would require the user to be able to push/pull thedevice, steer the device, and know that the device is sufficiently rigid(but not too rigid) to be used as desired.

An additional embodiment of a device 100 of the present disclosure isshown in FIG. 21. As shown in FIG. 21, a cross-sectional view of anelongated wrap 2100 is shown comprising one or more conductive elementsmay be used in connection with a core body 102, whereby wrapping thewrap 2100 around body 102 would produce a device 100 that is eitherfully or partially operable as a conductive device 100. For example, awrap 2100 can have a plurality of conductive wires 110 (which can be, inthis and in various other embodiments of the present disclosure,conductive traces that are deposited in or on a film, resulting in aprinted circuit) embedded therein (within a flexible wrap body 2102) orthereon (upon a flexible wrap body 2202) around a relative perimeter ofwrap body 2102, and when wrap 2100 is placed around a body 102, it caneither be affixed (using an adhesive 602, 1675 of the presentdisclosure) thereto or heat-shrinked (or shrink-wrapped) around body102. Wrap 2100, in at least one embodiment, may be completelycircumferential or otherwise fit completely around a portion of a body102, or it may be planar and wrapped around body 102. In aheat-shrinkable embodiment, the inner diameter of wrap 2100 may besomewhat larger than an outer diameter of body 102, and the heat-shrinkproperties of the wrap 2100 material itself would allow wrap 2100 to fitsecurely around body 102. In at least one embodiment, a wrap 2100 wouldhave dimensions to eventually fit around an 0.0131″ diameter body 102,whereby wrap 2100 has a thickness of approximately 0.0004″ and conductorwires 110 therein have an outer diameter of approximately 0.0004″ orless. In other embodiments, the conductor wires 110 can be as small as0.0001″ to 0.0003″ in diameter, or larger as desired. In at least oneembodiment, wrap 2100 itself (without any wires, electrodes, traces,sensors, connectors, etc., attached thereto or embedded therein) isapproximately 10 microns (0.0004″) thick, and the conductor wires 110(traces, for example) deposited thereon would locally increase thethickness of wrap 2100 to approximately 20 microns (0.0008″). In atleast one embodiment, wrap 2100 comprises a polyimide.

In various embodiments, wrap 2100 can comprise one or more conductorwires 110, an exemplary assembly 1800 of conductor wires 110,electrodes, traces, sensors, connectors, and the like attached theretoor embedded therein, including, but not limited to, an impedance portion800, a temperature portion 810, and a connection portion 830. Theconductor wires 110 (or conductive traces, as referenced above) can bein a straight configuration, a helical configuration, or any otherconfiguration whereby at least one conductive wire 110 or trace extendsthe desired length of wrap 2100. A complete wrap 2100 (including, forexample, conductor wires 110) would be flexible, so that the wrap 2100substrate itself is flexible and the conductor wires 110 are alsoflexible. An exemplary wrap 2100, an exemplary impedance substrate 1600,and/or an exemplary connector substrate 1675 of the present disclosurecan be positioned about a body 102 of the present disclosure or otherwires or catheters with or without grooves 104 defined therein, to format least a portion of an operable device 100 of the present disclosure.

If the conductor wires 110 are adjacent to one another and not shieldedfrom one another (as shown in an individual combination of six conductorwires in FIG. 21), there would be enough adjacent wires to transmit thedesired signal without excessive resistance. As resistance is directlyrelated to the diameter of the conductor wire 110 itself, additionalconductor wires 110 could be added as needed. For example, if a desiredresistance is achieved using a combination of six conductor wires 110 ofa particular diameter, and conductor wires having approximately ⅙ thediameter are desired, then resistance is increased by 36 (six squared),and as such, 36 conductor wires 110 would be needed to transmit anindividual signal. In an embodiment where six signals are transmittedusing device 100 simultaneously, a total of 216 (36×6) conductor wires110 would be needed in total to maintain the same level of resistance.In such an embodiment, the 216 conductor wires 110 could be placedcircumferentially about wrap 2100, with insulative spaces between eachgroup of 36 conductor wires 110, if desired. In addition, and in variousembodiments, conductive wires 110 of the present disclosure may have anynumber of cross-section configurations, such as round, square, orrectangular as described below.

An additional exemplary wrap 2100 embodiment is shown in FIG. 22. Asshown therein, a cross-sectional view of an elongated wrap 2100 is showncomprising one or more conductive elements within or upon wrap body 2102may be used in connection with a core body 102, whereby wrapping thewrap 2100 around body 102 would produce a device 100 that is eitherfully or partially operable as a conductive device 100. For example, andas shown in FIG. 22, a wrap 2100 can have a plurality of wide conductors2200 embedded therein or thereon, and when wrap 2100 is placed around abody 102, it can either be affixed (using an adhesive 602, 1675 of thepresent disclosure) thereto or heat-shrinked (or shrink-wrapped) aroundbody 102. Wide conductors, as shown in FIG. 22, can have a rectangularcross-section, or can have a quasi-rectangular cross-section, wherebythe relative smaller sides and/or the relative larger sides have acurvature. Examples of such wide conductors 2200 are shown in FIG. 22,noting that in any given embodiment, a device 2200 may have one or moreconfigurations of wide conductors 2200 therein or thereon.

In addition, and as shown in FIG. 22, an exemplary elongated wrap mayhave one or more shrink zones 2250 present therein, whereby shrink zones2250 are present in between portions of wrap 2100 that do not haveconductor wires 110 or traces. Shrink zones 2250, applicable to variouswrap embodiments, would allow said portions of wrap 2100 to shrink abouta core body 102, for example, while portions of wrap 2100 havingconductor wires 110, for example, may not be as susceptible to heatshrinking, for example.

An additional device embodiment 100 of the present disclosure is shownin FIG. 23. As shown in FIG. 23, device 100 comprises a body 102 havinga wavy configuration, whereby one or more conductor wires 110 (ortraces) may be positioned within grooves 104 defined within body 102.The wavy configuration, which may be within one plane, for example,would allow a user of said device 100 to steer the device 100 within aluminal organ of interest and allow for flexing of device 100 asdesired. The wavy configuration may be positioned in one or more placesabout body 102.

Additional embodiments of exemplary devices 100 of the presentdisclosure are shown in FIGS. 24A and 24B. As shown in FIGS. 24A and24B, by way of cross-section of a portion of said devices 100, devices100 comprise a body 102 having at least one planar side 2400 configuredso that one or more wide conductors 2200 (and/or conductor wires 110, ifdesired) may be positioned thereon. Contrary to the device 100embodiments shown in FIGS. 1B and 1D, for example, planar sides 2400 donot have, create, or form a pocket to receive one or more wideconductors 2200, while the grooves 104 shown in FIGS. 1B and 1D do forma pocket to receive one or more conductor wires 110. Wide conductors2200 (which could also be shown as being deposited conductive traces asreferenced herein), would be positioned on one or more planar sides 2400upon core body 102, so that a signal may be transmitted therethrough(from an electrode to a connector, for example).

Planar sides 2400, as shown in FIGS. 24A and 24B, define a planarsurface 2402, and wide conductors 2200 define a wide conductor surface2404, so that wide conductor 2200 could be placed directly upon planarside 2400, and so that planar surface 2402 and wide conductor surface2404 would contact one another. Such an embodiment would differ from anembodiment using a round conductor wire 110, as such a conductor wire110 would not have a flat surface to contact planar surface 2402 ofdevice 100. This would allow a wide conductor 2200 to be placed directlyupon a planar side 2400, and make placement of the same easier duringmanufacturing as wide conductor 2200 would not be prone to rolling offof planar side 2400 like a round conductor wire 110 would. In addition,and as referenced above, a trace (which would be placed on a planar side2400 like a wide conductor 2200 shown in FIGS. 24A and B) could beplaced directly on one or more planar sides 2400 during manufacturing,which would be a relatively easier process than attempting to place sucha trace about a curved surface.

In an embodiment where it is preferred to coat core body 102 with acoating 500, 600, a coating 500, 600 would be positioned about core body102, and a conductor wire 110 would be positioned upon coating 500, 600at one or more planar sides 2400. Any number of planar sides 2400 couldbe defined about core body 102, including one, two, three, or more,including the six planar sides 2400 shown in FIGS. 24A and 24B. In anembodiment having six planar sides 2400 and no other sides, core body102 would have a hexagonal cross-section. In various embodiments, and asshown in FIGS. 24A and 24B, an additional coating 500 (or 600) may bepositioned around some or all of core body 102 with conductor wires 110(or traces) positioned on one or more planar sides, so to smooth theouter dimension of said device 100. Coating 500 (or 600) may be presentat a relative corner 2450 of core body 102 with some thickness (as shownin FIG. 24A) or little to no thickness (as shown in FIG. 24B).

As referenced above, and as shown in cross-section in FIGS. 25A-25C, anumber of potential exemplary core body 102 configurations may be usefulin connection with one or more device 100 embodiments of the presentdisclosure. An exemplary multi-hole core 102, shown in cross-section inFIG. 25A and previously shown in cross-section in at least FIGS. 1C, 1D,2A, and 20B, may require a number of processing steps to potentiallygrind, etch, and/or extrude, for example, core body 102 to create themulti-hole core body 102 having one or more grooves 104 defined thereon.In addition, and in attempt to mimic or substantially meet one or moreproperties of a traditional 0.014″ diameter wire having a round core,such a multi-hole core could be at or between, for example, 0.013″ to0.0138″ in maximum diameter, or even as high as 0.014″ in maximumdiameter, not including any sort of coating 500, 600 or othercomponentry positioned thereon.

An exemplary hexagonal core body 102 configuration, shown incross-section in FIG. 25B and previously shown in cross-section in FIGS.24A and 24B, may also require one or more processing and/or shapingsteps so that the resulting core body 102 resembles a hexagonal core. Inattempt to mimic or substantially meet one or more properties of atraditional 0.014″ diameter wire having a round core, such a hexagonalcore could be at or between, for example, 0.0127″ to 0.0138″ in maximumdiameter, or even as high as 0.014″ in maximum diameter, not includingany sort of coating 500, 600 or other componentry positioned thereon. Asshown in FIG. 25B, for example, such an embodiment has six planar sides2400, each defining a planar surface 2402, as previously shown in FIGS.24A and 24B. However, and as shown in FIG. 25B, an exemplary device 100embodiment with a hexagonal core body 102 may further have one or morereduced corners 2500, whereby the one or more reduced corners 2500define one or more planar edges 2502 in between the one or more planarsides 2400. In such an embodiment, the overall core body 102 diametercan remain at a desired size, but the amount of core body 102 (incross-sectional area, for example) for that same diameter would begreater as compared to a hexagonal core body 102 without any reducedcorners 2500. For any given diameter, for example, the larger/longer theplanar edges 2502, the greater the cross-sectional area of core body102, up until the size/length of planar edges 2502 is equal to thesize/length of planar sides 2400, forming an effective twelve-sided corebody 102 having sides of equal size.

A solid round core body 102, such as shown in FIG. 25C, may require theleast amount of processing (given its native round shape), and invarious embodiments, the core body 102 would have a diameter at orbetween 0.013″ up to 0.014″.

Table 1 below shows data in connection with various core body 102configurations and sizes. As listed therein, various core bodies (in the“Description” column) of various maximum diameters (in inches in the“Diameter” column) were tested, with the flexural rigidities (EI of thedimension N·mm² (a combination of E, which is the effective Young'sModulus of the composite material and I is the second moment of inertia)as previously referenced above) and the amount of degradation ascompared to a 0.013″ standard round core.

TABLE 1 Description Diameter (in) Flexural Rigidity Degradation Round0.013 116.71 Standard Hexagon 0.0127 73.26 −37.23% 0.12″ pitch helical0.013 73.34 −37.16% single-groove 0.12″ pitch helical 0.0134 75.6−35.23% single-groove Hexagon 0.013 80.43 −31.08% Hexagon 0.0131 82.94−28.94% Round 0.012 84.73 −27.40% 0.12″ pitch helical 0.013 88.87−23.85% multi-hole 0.12″ pitch helical 0.0134 91.6 −21.51% multi-holeHexagon 0.0136 96.37 −17.45% Round 0.0125 99.76 −14.52% Hexagon 0.0138102.13 −12.49%

As shown in Table 1, the tested device 100 embodiment with the highestflexural rigidity, and thus the lowest amount of degradation as comparedto the standard 0.013″ diameter round core, had the 0.0138″ diameterhexagonal core body 102. One exemplary goal, with the various core body102 configurations, is to balance degradation with the variousconstruction options so to arrive at electrical performance withacceptable mechanical performance and behavior.

With respect to the various types of conductor wires 110 (or traces110), certain configurations may be preferred over others. For thepurposes of this disclosure, and to clarify prior references herein toconductor wires 110 or traces, element “110” shall generally apply toboth conductor wires and traces. As such, references herein to conductorwires 110 may also refer to traces, and the term traces 110 may also beused, which may refer to wire embodiments as well.

In various embodiments, and if round or flat conductor wires 110 areused, a 5:1 ratio of width:height would may be preferred, and conductorwires 110 may comprise copper. In many embodiments, flat conductor wires110 cannot be independently insulated. If a trace 110 (such as aconductive polymer or plating material) is used, a resistivity of 0.0001Ω-cm would be needed, and such trace 110 material may be used tocompletely or partially fill a groove 104, for example, or be placedaround a wire.

Another exemplary device 100 embodiment of the present disclosure isshown in cross-section in FIG. 26A. As shown therein, device 100comprises a multi-hole (or multi-slot) core body 102 configuration,shown by way of example with six grooves 104. Such an embodiment, forexample, may have a core diameter at or between 0.013″ to 0.0136″, so tonot exceed 0.014″ with coating 600 (or coating 500) positioned aroundcore body 102. Core body 102, with coating 600 (or coating 500)positioned thereon, and in at least one embodiment, would have anoverall diameter of or approximately 0.0139″. Coating 500, 600, in atleast one embodiment, may comprise polytetrafluoroethylene (PTFE). Insuch an embodiment, core body 102 is itself conductive (stainless steel,for example), and so that conductor wires 110 do not come intoconductive contact with core body 102, each conductor wire 110 wouldhave a coating 500 (or coating 600) positioned thereon as shown in FIG.26A. In at least one embodiment, conductor wires 110 would have adiameter at or between 0.0015″ to 0.003″, and may comprise, for example,stainless steel (1.15 kΩ/190 cm) or copper (28Ω/190 cm). Such anexemplary embodiment is anticipated to have an overall degradation (asdescribed in connection with Table 1 above) of between approximately20-23%.

An additional device 100 embodiment of the present disclosure is shownin cross-section in FIG. 26B. As shown in FIG. 26B, device 100 comprisesa hexagonal configuration core body 102 surrounded by a first coating500 (or coating 600). An optional adhesive agent 602 (not shown in FIG.26B) may be used to secure conductor wires 110 to the coating 500surrounding core body 102. In at least one embodiment, conductor wires110 are positioned upon the coating 500 surrounding core body 102without adhesive agent 602. A second coating (shown as coating 600 inFIG. 26B) may be applied around device 100 so that coating 600 encasesconductor wires 110. So to form an overall outer round shape, a thirdcoating (shown as coating 2600 in the figure, which may also be coating500 or coating 600) is used to surround coating 600. In such anembodiment, for example, core body 102 may itself have a diameter of orapproximately 0.0127″ at its largest dimension, and conductor wires 110may comprise wires having a width of or approximately 0.002″ and aheight of or approximately 0.0004″. Such a conductor wire 110 dimension,if comprising copper (62Ω/190 cm at that size), would be able totransmit signals therethrough as needed. With all coatings applied(coatings 500, 600, 2600), an exemplary device 100 of the presentdisclosure may have an overall outer diameter of or approximately0.0139″.

Additional device embodiments using conductive traces 110 (or conductiveadhesives, for example), are shown in FIGS. 27A, 27B, and 28A. As shownin the exemplary device 100 embodiment of FIG. 27A, device 100 comprisesa core body 102 with a round cross-section, and in at least oneembodiment, the round core body 102 has a diameter of or approximately0.013″. Other diameters, such as diameters larger than 0.013″ andapproaching 0.014″, may be used in other embodiments. As referencedabove, a 0.013″ round stainless steel core is the standard used todetermine flexural rigidity and degradation, so such a core, as comparedto other cores, has zero degradation. As shown in FIG. 27A, device 100comprises a first coating 500 around core body 102, which may be apolyimide coating 500 or another coating 500 suitable to prohibit asignal from transferring from core body 102 to or from conductor wires110 or traces 110. Traces 110, which may be, for example, gold or coppertraces having dimensions of or approximately 0.0002″×0.006″ (60Ω/190 cmat that size), would be positioned on top of coating 500. In at leastone embodiment, one trace 110 is initially used that spans most or allof an entire device 100 circumference at a given location along a lengthof device 100, and one or more gaps 2700 may be formed within trace 110using a laser and/or a physical device to score/cut trace 110 at one ormore locations. Gaps 2700, in various embodiments, may be relativelysmall (0.001″-0.002″, for example), so that a larger amount of trace 110can be used. Therefore, and as shown in FIG. 27A, for example, sixtraces 110 could be applied to coating 500, with six gaps 2700 definedtherebetween, or fewer traces 110 could be applied with one or more gaps2700 formed therein after initial trace 110 placement. After trace 110placement, a second coating 600 may be applied around device 100, sothat traces 110 are insulated from the outside of device 100. Such adevice 100 embodiment may then have an overall diameter at or below0.014″, if 0.014″ is a maximum diameter allowed/desired for a particularapplication.

The device 100 embodiments shown in FIGS. 26A, 26B, 27A, and othersreferenced herein, are shown in cross-section, with all conductor wires110 (or traces 110) surrounded by some sort of coating so thatwires/traces 110 are not exposed on a relative outside of the devices100. However, when forming portions of devices 100 (such as impedanceportions 800 and/or connection portions 830), the various electrodesand/or connectors would be electrically coupled/connected towires/traces 110 at or near the locations where electrodes and/orconnectors are exposed on the outside of devices 100. Suchconfigurations allow wires/traces 110 to be properly shielded and alsoallow for proper connection of the various electrodes/connectors.

An additional device 100 embodiment of the present disclosure is shownin FIG. 27B, wherein core body 102 has a hexagonal configuration. Suchan embodiment, for example, may also have a coating 500 surrounding corebody 102, and one or more traces 110 positioned upon coating 500. Astainless-steel hexagonal core having a largest diameter of 0.0127″ (oranother size) may be used, and if such a size is used, the initial corebody 102 degradation is approximately 37% as compared to a 0.013″ roundcore body. If six traces 110 are used, for example, a gap 2700 would bedefined between each trace 110. If less than six traces 110 are used,one or more gaps 2700 may then be laser or mechanically cut intotrace(s) 110 to form the desired number of traces 110, which may be anynumber of total traces 110 (1, 2, 3, or more). In at least oneembodiment, gaps may be at or approximately 0.001″, and gold or coppertraces 110 of or approximately 0.0001″×0.006″ (120Ω/190 cm at that size)may surround core body 102. A second coating 600 may then be used tosurround all traces 110, forming the external dimensions of device 100as with second coating 600 in FIG. 27A, for example.

Yet another exemplary device 100 embodiment of the present disclosure isshown in FIG. 28A. As shown therein, device 100 has a hexagonal corebody 102 (such as a 0.0127″ stainless steel core), surrounded by a firstcoating 500. First coating 500, if used, may comprise polyimide,polytetrafluoroethylene (PTFE), or another suitable material. If anadhesive agent 602 is used to facilitate application of conductive wires110 or traces 110 therein, such an agent may comprise a flexible silveradhesive 602 and may be applied at a dimension at or about0.0005″×0.0036″ (1.61Ω/190 cm at that dimension) at or near wires/traces110. A second coating 600 would then be applied around wires/traces 110to form the overall cross-sectional dimension of device 100, which wouldbe larger than the initial core body 102 up to 0.014″ should 0.014″ be amaximum diameter. As such, the device 100 embodiments shown in FIGS.26B, 27B, and 28A each have hexagonal core bodies 102 but an overallround device 100 shape in cross-section.

In addition to the foregoing, and as referenced herein in connectionwith at least FIG. 17B, a relative distal end of an exemplary deviceembodiment 100 of the present disclosure may have any number ofconfigurations. As shown in FIG. 28B, three separate distal end profilesare shown, with profile 1 being a known profile in the art, and profiles2 and 3 being exemplary profiles 2800 of the present disclosure. Profile2, as shown in FIG. 28B, has the same initial overall distal end size asprofile 1 (the first portion), but tapers to a smaller second portionthan profile 1, and then to the same final portion as profile 1. Such anembodiment may relate to a device 100 of the present disclosure having anitinol tip. Profile 3, also as shown in FIG. 28B, has the smallestoverall distal end (first portion), and tapers to a second portion andthen to a third portion, with each portion being the smallest of thethree profiles. Profile 3, for example, may relate to a device 100embodiment having a stainless steel tip.

FIGS. 29A and 29C show exemplary distal portions 2900 of devices 100 ofthe present disclosure. As shown therein, distal portions 2900 includean impedance portion 800 having electrodes 802, 804, 806, 808, andthermistor wire ends 812, 814 positioned relative to impedance portion800. Various conductor wires/traces 110 connect to impedance portion 800and thermistor wire ends 812, 814, whereby, for example, conductive pathconnections may be made from the backside of electrodes 802, 804, 806,808 (which may be electrode bands) to conductive wires/traces 110. Acompliant portion 820 (distal coil) with an atraumatic tip 822, as shownin the exemplary embodiments in FIGS. 29A and 29C, is at the very distalend of device 100. Such a distal portion 2900 may have such componentryas part of device 100 and not part of an impedance substrate 1600, ormay have some componentry (such as some conductive wires/traces 110),while impedance substrate 1600 has the remaining components, includingadditional conductive wires/traces, as shown in FIGS. 29B and 29C.Impedance substrate 1600, shown in FIGS. 29B and 29C, comprises aflexible substrate 1602 (such as polyimide, including but not limited toKapton) having electrodes 802, 804, 806, 808, and thermistor wire ends812, 814 thereon/therein, with multiple conductor wires/traces 110coupled to the same. Impedance substrate 1600 can then be placed ondevice 100, as shown in FIG. 29C, so that conductor wires/traces 110 ofdevice 100 can electrically couple to conductor wires/traces 110 ofimpedance substrate 1600. Impedance substrate 1600 may be wrapped arounddevice 100 in a number of configurations, including spiral-wrapped. Withsuch an impedance substrate 1600, the conductive path connections may beformed from the backside of the impedance substrate 1600 or at flanges,for example, on the relative proximal end of impedance substrate 1600.With such an impedance substrate 1600, electrode spacing toleranceshould be repeatedly achievable. Various adhesives (such as adhesives1650 or 602) can be used to couple the impedance substrate 1600 todevice 100, if desired.

Similar distal portions 2900 to those shown in FIGS. 29A and 29C arepreviously referenced herein in FIGS. 16C and 16D. Connector substrates1675, such as those shown in FIGS. 16E-16I, can be positioned around arelative proximal device 100 portion, whereby, in addition to thevarious embodiments previously referenced herein, various gold traces110 can be laser patterned thereon, with epoxy injection molding used toposition the various conductors.

While various embodiments of devices and systems for obtainingconductance data and methods of manufacturing and using the same havebeen described in considerable detail herein, the embodiments are merelyoffered as non-limiting examples of the disclosure described herein. Itwill therefore be understood that various changes and modifications maybe made, and equivalents may be substituted for elements thereof,without departing from the scope of the present disclosure. The presentdisclosure is not intended to be exhaustive or limiting with respect tothe content thereof.

Further, in describing representative embodiments, the presentdisclosure may have presented a method and/or a process as a particularsequence of steps. However, to the extent that the method or processdoes not rely on the particular order of steps set forth therein, themethod or process should not be limited to the particular sequence ofsteps described, as other sequences of steps may be possible. Therefore,the particular order of the steps disclosed herein should not beconstrued as limitations of the present disclosure. In addition,disclosure directed to a method and/or process should not be limited tothe performance of their steps in the order written. Such sequences maybe varied and still remain within the scope of the present disclosure.

1. A device, comprising: an elongated core body having a length, aperimeter, a cross-sectional configuration, and a first groove definedtherein; and a plurality of conductive elements positioned around theperimeter of the core body and extending a majority of the length of thecore body, the plurality of conductive elements surrounded by a firstsubstantially or completely non-conductive coating; wherein the firstgroove is configured to receive at least one conductive element of theplurality of conductive elements therein; and wherein the device, havingthe first substantially or completely non-conductive coating, has anoverall round cross-section and an overall diameter betweenapproximately 0.013″ and approximately 0.050″.
 2. The device of claim 1,wherein the plurality of conductive elements are selected from the groupconsisting of a plurality of conductive wires and a plurality ofconductive traces.
 3. The device of claim 1, wherein the elongated corebody has a second groove defined therein, and wherein the second grooveis configured to receive at least another conductive element of theplurality of conductive elements therein.
 4. The device of claim 3,wherein the elongated core body is at least partially surrounded by thefirst substantially or completely non-conductive coating, and whereinthe at least one conductive element and the at least another conductiveelement are not individually coated prior to placement with the firstgroove and the second groove.
 5. The device of claim 1, wherein thecross-sectional configuration is selected from the group consisting of around cross-sectional configuration and a hexagonal cross-sectionalconfiguration defining six planar sides.
 6. The device of claim 1,wherein the cross-sectional configuration comprises a hexagonalcross-sectional configuration defining six planar sides and furtherdefining one or more reduced corners.
 7. The device of claim 6, whereinthe elongated core body is at least partially surrounded by the firstsubstantially or completely non-conductive coating, and wherein theplurality of conductive elements are positioned on the firstsubstantially or completely non-conductive coating.
 8. The device ofclaim 7, wherein the plurality of conductive elements comprise aplurality of conductor wires having a rectangular cross-section.
 9. Thedevice of claim 7, wherein the device is further surrounded by a secondsubstantially or completely non-conductive coating, the secondsubstantially or completely non-conductive coating defining the overallround cross-section.
 10. The device of claim 1, wherein the elongatedcore body is at least partially surrounded by the first substantially orcompletely non-conductive coating, and wherein the plurality ofconductive elements are positioned on the first substantially orcompletely non-conductive coating.
 11. The device of claim 10, whereinthe plurality of conductive elements are selected from the groupconsisting of a plurality of conductive wires and a plurality ofconductive traces.
 12. The device of claim 10, wherein the plurality ofconductive elements comprises a plurality of conductive traces producedby initially placing one or more conductive traces upon the elongatedcore body at least partially surrounded by the first substantially orcompletely non-conductive coating and removing portions of the one ormore conductive traces to result in the plurality of conductive traces.13. The device of claim 1, further comprising: a detector coupled to thedevice at or near a distal end of the device, the detector configured toobtain conductance data when the device is operated in a fluidenvironment.
 14. The device of claim 13, wherein the detector is coupledto one or more of the plurality of conductive elements, so that a signalmay be transmitted along the one or more of the plurality of conductiveelements to and/or from the detector, and wherein the detector comprisestwo detection electrodes positioned in between two excitationelectrodes, wherein the excitation electrodes are operable to generatean electric field within a luminal organ that can be detected by thedetection electrodes to obtain conductance data indicative of theluminal organ.
 15. The device of claim 14, further comprising: twothermistor wire ends operable to detect a temperature of a fluid withinthe luminal organ.
 16. The device of claim 1, wherein the elongated corebody has two or more additional grooves defined therein, each of the twoor more additional grooves configured to receive a conductive element ofthe plurality of conductive elements therein.
 17. A device, comprising:an elongated core body having a length, a perimeter, a cross-sectionalconfiguration selected from the group consisting of a roundconfiguration and a hexagonal configuration, and a first groove definedtherein; a plurality of conductive elements positioned around theperimeter of the core body and extending a majority of the length of thecore body, the plurality of conductive elements surrounded by a firstsubstantially or completely non-conductive coating; and a detectorcoupled to the device at or near a distal end of the device and operablyconnected to one or more of the plurality of conductive elements, thedetector configured to obtain conductance data when the device isoperated in a fluid environment and to transmit the conductance dataalong one or more of the plurality of conductive elements; wherein thefirst groove is configured to receive at least one conductive element ofthe plurality of conductive elements therein; and wherein the device,having the first substantially or completely non-conductive coating, hasan overall round cross-section and an overall diameter betweenapproximately 0.013″ and approximately 0.050″.
 18. The device of claim17, wherein the detector comprises two detection electrodes positionedin between two excitation electrodes, wherein the excitation electrodesare operable to generate an electric field within a luminal organ thatcan be detected by the detection electrodes to obtain conductance dataindicative of the luminal organ.
 19. The device of claim 17, furthercomprising: two thermistor wire ends operable to detect a temperature ofa fluid within the luminal organ.
 20. A device, comprising: an elongatedcore body having a length, a perimeter, a cross-sectional configuration,and a first groove defined therein; a plurality of conductive elementspositioned around the perimeter of the core body and extending amajority of the length of the core body, the plurality of conductiveelements surrounded by a first substantially or completelynon-conductive coating; a detector coupled to the device at or near adistal end of the device and operably connected to one or more of theplurality of conductive elements, the detector configured to obtainconductance data when the device is operated in a fluid environment andto transmit the conductance data along one or more of the plurality ofconductive elements; wherein the first groove is configured to receiveat least one conductive element of the plurality of conductive elementstherein; wherein the device is further surrounded by a secondsubstantially or completely non-conductive coating, the secondsubstantially or completely non-conductive coating defining the overallround cross-section; and wherein the device, having the firstsubstantially or completely non-conductive coating and the secondsubstantially or completely non-conductive coating, has an overall roundcross-section and an overall diameter between approximately 0.013″ andapproximately 0.050″.